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近日，EDQM正式發(fā)布歐洲藥典第12版，這是首版僅提供在線版本的歐洲藥典，從本版歐洲藥典開始，歐洲藥典將僅提供在線版本，在線版歐洲藥典內(nèi)容包含現(xiàn)行、待實(shí)施和某些以前的歐洲藥典版本，并支持強(qiáng)大的搜索工具、信息中心和新的篩選工具和屬性無縫地檢索到他們需要的內(nèi)容。第11 版的所有用戶在過渡期內(nèi)仍然保持有效，直到2025 年底。自2026 年1 月1 日起，用戶將只能訂閱在線版本。
EP12的新特性
在線訪問
從第EP12.1開始，歐洲藥典將完全在線提供，所有文本都可在改進(jìn)的、用戶友好的平臺上供訂閱者使用。會用一種更直觀的方法，更現(xiàn)代化的界面，快速高效地訪問所需的內(nèi)容，具有更強(qiáng)的搜索功能、高效的儀表板、新的篩選功能和屬性等等。
全新的構(gòu)成
新的版本由三卷組成（編號12.1-12.3），對應(yīng)2025年歐洲藥典委員會會議在其中通過的新文本和修訂文本，將取代以前三年一個(gè)版本，八個(gè)增補(bǔ)的更新周期。
此外，將引入365天的許可模式，簡化許可管理。歐洲藥典將過渡到新的平臺和出版模式，以便順利進(jìn)行這些更改。
所有第11版的訂閱將在過渡期內(nèi)有效，直至2025年底。
自2026年1月1日起，僅新平臺可用。
全新的功能
新的歐洲藥典平臺功能包括：
可訪問所有現(xiàn)行有效文本以及自第11.0卷以來出版的文本；
文本狀態(tài)指示燈系統(tǒng)（綠色表示“有效”，橙色表示“尚未生效”，紅色表示“不再生效”）；
文本內(nèi)嵌菜單，方便在不同版本之間導(dǎo)航；
改進(jìn)的篩選功能、預(yù)定義搜索和更新的結(jié)果顯示；
訪問檔案和知識數(shù)據(jù)庫中的補(bǔ)充信息。
全新歐洲藥典365 天許可證提供一年的歐洲藥典在線平臺訪問權(quán)限，自許可證密鑰(EPID) 激活之日起生效。 功能包括：
顯示許可證剩余席位數(shù)量和剩余天數(shù)的計(jì)數(shù)器；
許可證續(xù)訂選項(xiàng)，并自動(dòng)重新分配用戶訪問權(quán)限；
到期前自動(dòng)發(fā)送電子郵件提醒。
歐洲藥典網(wǎng)站提供英語和法語雙語版本，兼容最新版本的Chrome、Edge、Firefox 和Safari瀏覽器。
本版歐洲藥典發(fā)布的新文本、修訂和校正內(nèi)容如下：
Brief descriptions of the modifications that have been made to new, revised and corrected texts adopted by the European Pharmacopoeia Commission at the November session and published in Issue 12.1 are provided below. Please note that these descriptions are not provided systematically for new and corrected texts, but are instead provided on a case - by - case basis. This information is reproduced in the knowledge database under View history.
對在歐洲藥典委員會11 月會議上通過并在第12.1 期發(fā)布的新文本、修訂文本和校正文本所做修改的簡要說明。請注意，這些描述并非系統(tǒng)地針對新文本和校正文本提供，而是根據(jù)具體情況提供。此信息復(fù)制自知識數(shù)據(jù)庫的 “查看歷史記錄” 視圖。
All revised, corrected or deleted parts of a text published in the European Pharmacopoeia are indicated by change marks in the form of triangles.
已發(fā)布在《歐洲藥典》中的文本的所有修訂、校正或刪除部分均以三角形形式的變更標(biāo)記指示。
GENERAL CHAPTERS
通論章節(jié)
1. General notices
1. 總則
As a result of the transition of the European Pharmacopoeia to a solely online format from the 12th Edition, several changes to the way in which information about texts is displayed have been introduced in order to improve the user experience. Linked to this, the General Notices has undergone a minor revision to update the information about the organisation of the publication cycle and the general monographs.
由于《歐洲藥典》從第12 版起轉(zhuǎn)為僅在線形式，為改進(jìn)用戶查看文本信息的方式，進(jìn)行了幾處更改。與此相關(guān)的是，《通則》進(jìn)行了小幅修訂，以更新有關(guān)出版物周期和通論的信息。
1.1.1 General Principles: wording "edition or supplement" replaced by "issue" to reflect the terminology used to describe the new publication cycle where each edition is composed of three "issues".
1.1.1 一般原則：“版本或增刊” 的表述被 “期” 取代，以反映用于描述每個(gè)版本所包含的三個(gè) “期” 的新出版周期術(shù)語。
1.4 General monographs and general monographs on dosage forms: section1.4 of the General Notices has been revised to define more clearly which monographs are considered "general monographs" and to improve the overall clarity of the section.
1.4 通論和劑型通論：《總則》的1.4 節(jié)已修訂，以更明確地界定哪些專論被視為 “通論”，并提高該節(jié)的整體清晰度。
Separate to the changes driven by the new European Pharmacopoeia format, the following modification has also been made.
此外，為推動(dòng)《歐洲藥典》格式的更新，還進(jìn)行了以下修改：
1.1.2.6 Pharmacopoeial harmonisation: wording revised to indicate that the Pharmacopoeial Discussion Group (PDG) has more than 3 members.
1.1.2.6 藥典協(xié)調(diào)：措辭修訂，以表明藥典討論小組(PDG) 有超過3 名成員。
2.2.39. Molecular mass distribution in dextrans
2.2.39. 葡聚糖中的分子量分布
System suitability: criteria revised from fixed ranges to relative ranges around the assigned value of the N - CRSs; CRSs used in system suitability replaced in line with revised criteria.
系統(tǒng)適用性：標(biāo)準(zhǔn)從固定范圍修訂為圍繞指定N - CRSs 值的相對范圍；用于系統(tǒng)適用性的N - CRSs 已被修訂標(biāo)準(zhǔn)取代。
2.5.42. N - Nitrosamines in active substances and medicinal products
2.5.42. 活性物質(zhì)和藥品中的N-亞硝胺
Inclusion of sartan - containing medicinal products in the scope of procedures A and C, and procedure A can be applied as a quantitative test. Addition of the requirement for performing a validation when a procedure is modified beyond the allowable adjustments of chromatographic conditions listed in Chromatographic separation techniques (2.2.46).
將含沙坦的藥品納入程序A 和C 的范圍，程序A 可用作定量測試。當(dāng)程序在允許的調(diào)整范圍之外修改時(shí)，增加了進(jìn)行驗(yàn)證的要求，色譜條件見 “色譜分離技術(shù)”(2.2.46)。
2.9.34. Bulk density of powders
2.9.34. 粉末的堆密度
This minor revision corresponds to Revision 4, Correction 2 (based on the Pharmacopoeial Discussion Group (PDG) working procedure) within the Pharmacopoeial harmonisation process. The coordinating pharmacopoeia is the Ph. Eur.
此次小修訂對應(yīng)于藥典協(xié)調(diào)過程中依據(jù)藥典討論小組（PDG）工作程序的第4 次修訂、第2 次勘誤。協(xié)調(diào)藥典為《歐洲藥典》。
Compared to the general chapter published in Supplement 11.5 of the Ph. Eur., the following changes are proposed:
與《歐洲藥典》增補(bǔ)本11.5 中發(fā)布的通用章節(jié)相比，建議進(jìn)行以下更改：
Tapped bulk density section:
振實(shí)堆密度部分：
- titles of Method 1 and Method 2 changed by adding 'high drop' and 'low drop' to clearly identify the two methods;
-方法1 和方法2 的標(biāo)題中添加 “高落差” 和 “低落差”，以明確區(qū)分這兩種方法；
- Figure 3: inclusion of both drop heights as per Method 1 and Method 2;
-圖3：納入方法1 和方法2 的兩種落差高度；
- 'Dimensions in millimetres' deleted from below the caption of Figure 3 as dimensions given in the figure itself;
-從圖3 標(biāo)題下方刪除 “以毫米為單位的尺寸”，因?yàn)槌叽缫言趫D中給出；
- Method 2: significant figure added for the drop (from '3' to '3.0') to indicate the necessary precision.
-方法2：為落差添加有效數(shù)字（從 “3” 改為 “3.0”），以表明必要的精度。
5.1.9. Guidelines for using the test for sterility
5.1.9. 無菌檢查使用指南
The revised general chapter allows the use of alternative methods according to general chapter 5.1.6. Alternative methods for control of microbiological quality.
修訂后的通用章節(jié)允許根據(jù)通用章節(jié)5.1.6 “微生物質(zhì)量控制的替代方法” 使用替代方法。
In the Precautions against microbial contamination section, the classification for a laminar - air flow cabinet and its location have been removed because this type of information is usually not defined in the Ph. Eur. and is described in other relevant documents (e.g. Annex 1 of the EudraLex - Volume 4: Good manufacturing practice).
在防止微生物污染的預(yù)防措施部分，已刪除超凈工作臺的分類及其位置，因?yàn)榇祟愋畔⑼ǔ２辉凇稓W洲藥典》中定義，而是在其他相關(guān)文件（如《歐盟藥品法規(guī)匯編》第4 卷附錄1：良好生產(chǎn)規(guī)范）中描述。
The line stating that the sterility test is the only analytical method available to the authorities has been removed.
聲明無菌檢查是當(dāng)局可用的唯一分析方法的內(nèi)容已被刪除。
Sampling plan considerations have been completed in order to also provide recommendations for terminally sterilised products and lyophilised products.
取樣計(jì)劃的考慮因素已完善，以便也為最終滅菌產(chǎn)品和凍干產(chǎn)品提供建議。
Recommendations for sterility test invalidation are no longer limited to condition (d) of general chapter 5.6.1. Sterility.
無菌檢查失效的建議不再局限于通用章節(jié)5.6.1 “無菌” 中的條件(d)。
Editorial changes have been made throughout the text for greater clarity.
為使內(nèi)容更清晰，全文進(jìn)行了編輯性修改。
Editorial modification of the French title from "Indications sur l'application de l'essai de stérilité" to "Recommendations pour la réalisation de l'essai de stérilité".
將法語標(biāo)題從 “Indications sur l'application de l'essai de stérilité” 編輯修改為 “Recommendations pour la réalisation de l'essai de stérilité”。
5.22. Names of herbal drugs used in traditional Chinese medicine
5.22. 中藥中使用的草藥名稱
Table updated to include 2 new monographs.
表格已更新，納入2 個(gè)新專論。
VACCINES FOR VETERINARY USE
獸用疫苗
Foot - and - mouth disease (ruminants) vaccine (inactivated) (0063)
口蹄疫（反芻動(dòng)物）疫苗（滅活）(0063)
Immunogenicity.
免疫原性。
- the validity criterion and animal welfare statement for the PD50 and PPG tests have been separated for greater clarity;
- 為更清晰起見，PD50 和PPG 試驗(yàn)的有效性標(biāo)準(zhǔn)和動(dòng)物福利聲明已分開。
the wording of the validity criterion for the above - mentioned tests has been clarified (lesions at sites other than the tongue replaced by a reference to lesions on the feet). This is to reflect the current practice of the EU FMD Reference Laboratories and FMD vaccine manufacturers, in that foot lesions, which do not score the same as lesions on the head. Indeed, mouth lesions may be caused by local spread of the virus from the inoculation site and are not necessarily reflective of generalised infection; they should not therefore be recorded.
上述測試的有效性標(biāo)準(zhǔn)措辭已得到澄清（將 “舌部以外部位的病變” 替換為對足部病變的提及）。這是為了反映歐盟口蹄疫（FMD）參考實(shí)驗(yàn)室和口蹄疫疫苗制造商的當(dāng)前做法，即足部病變的評分與頭部病變不同。實(shí)際上，口腔病變可能是由病毒從接種部位局部傳播引起的，不一定反映全身性感染；因此，不應(yīng)記錄這些病變。
HERBAL DRUGS AND HERBAL DRUG PREPARATIONS
草藥及草藥制劑
Adhatoda vasica leaf (2738)
鴨嘴花（2738）
Assay: methanol content in the test and reference solutions reduced to avoid artefacts and improve shape of peak due to vasicine.
含量測定：降低測試溶液和對照溶液中的甲醇含量，以避免偽影，并改善鴨嘴花堿峰的形狀。
Fleeceflower root (2433)
何首烏（2433）
Definition: botanical name updated.
定義：植物學(xué)名已更新。
Identification B: illustration of powdered herbal drug introduced and its legend integrated into text of Identification B.
鑒別B：引入了草藥粉末的插圖，其圖例已整合到鑒別B 的文本中。
Identification C: analytical procedure improved, harmonised with that of Polygonum multiflorum stem (2725) and aligned with general chapter 2.8.25.
鑒別C：分析程序得到改進(jìn)，與何首烏藤（2725）的程序協(xié)調(diào)一致，并與通論2.8.25 保持一致。
Assay: grade of solvents used in the mobile phase amended in accordance with the Technical Guide (2022).
含量測定：流動(dòng)相中使用的溶劑等級已根據(jù)《技術(shù)指南》（2022 年）進(jìn)行了修訂。
Fourstamen stephania root (2478)
千金藤（2478）
Identification B: illustration of powdered herbal drug introduced and its legend integrated into text of Identification B.
鑒別B：引入了草藥粉末的插圖，其圖例已整合到鑒別B 的文本中。
Identification C: analytical procedure improved and aligned with general chapter 2.8.25.
鑒別C：分析程序得到改進(jìn)，并與通論2.8.25 保持一致。
Assay: grades of solvents used in the mobile phase amended in accordance with the Technical Guide (2022).
含量測定：流動(dòng)相中使用的溶劑等級已根據(jù)《技術(shù)指南》（2022 年）進(jìn)行了修訂。
Wild pansy (flowering aerial parts) (1855)
三色堇（開花地上部分）（1855）
Identification: macroscopic description updated; illustration of powdered herbal drug introduced and its legend integrated into text; TLC replaced by high - performance thin - layer chromatography (HPTLC) in accordance with general chapter 2.8.25.
鑒別：宏觀描述已更新；引入了草藥粉末的插圖，其圖例已整合到文本中；按照通論2.8.25，薄層色譜法（TLC）已被高效薄層色譜法（HPTLC）取代。
Loss on drying: limit tightened based on batch data.
干燥失重：根據(jù)批次數(shù)據(jù)收緊限度。
Cadmium: maximum limit increased based on batch data.
鎘：根據(jù)批次數(shù)據(jù)提高最大限量。
Assay: unspecific absorbance assay replaced by more specific HPLC.
含量測定：非特異性吸光度測定已被更具特異性的高效液相色譜法（HPLC）取代。
HOMOEOPATHIC PREPARATIONS
順勢療法制劑
Homoeopathic preparations: introduction (90006)
順勢療法制劑：簡介（90006）
Homoeopathic preparations: introduction has been corrected to remove the reference to "general monographs", as from 12.1 the homoeopathic general monographs are no longer located in section 13 Homoeopathic preparations but instead in section 06 General monographs (Homoeopathic preparations (1038), Herbal drugs for homoeopathic preparations (2045), Mother tinctures for homoeopathic preparations (2029), Methods of preparation of homoeopathic stocks and potentisation (2371)) and section 07 Dosage forms (Pillules for homoeopathic preparations (2153), Homoeopathic pillules, impregnated (2079) and Homoeopathic pillules, coated (2786)).
順勢療法制劑：簡介已修正，刪除了對 “通論” 的引用，因?yàn)閺?2.1 起，順勢療法通論不再位于第13 部分順勢療法制劑中，而是位于第06 部分通論（順勢療法制劑（1038）、順勢療法用草藥（2045）、順勢療法母酊劑（2029）、順勢療法儲備液和稀釋制備方法（2371））以及第07 部分劑型（順勢療法小丸（2153）、浸漬順勢療法小丸（2079）和包衣順勢療法小丸（2786））中。
MONOGRAPHS
各論
Aluminium hydroxide, hydrated, for adsorption (1664)
用于吸附的水合氫氧化鋁（1664）
Sedimentation: the wording has been modified to clarify the requirements.
沉降：措辭已修改，以明確要求。
Nitrates: in terms of the colour produced, the analytical procedure is not able to discriminate between amounts greater than 1 μg; the preparation of the solution has been modified to correct this issue.
硝酸鹽：就產(chǎn)生的顏色而言，分析程序無法區(qū)分大于1 微克的量；溶液的制備已修改以糾正此問題。
Arsenic: in line with Ph. Eur. implementation strategy for the ICH Q3D guideline on elemental impurities (please see Press release), it is proposed to delete the test.
砷：根據(jù)歐洲藥典（Ph. Eur.）對人用藥品技術(shù)要求國際協(xié)調(diào)理事會（ICH）Q3D 元素雜質(zhì)指南的實(shí)施策略（請參閱新聞稿），建議刪除該測試。
Amitriptyline hydrochloride (0464)
鹽酸阿米替林（0464）
First identification: tests relabelled due to addition of the second identification sub - section.
首次鑒別：由于添加了第二次鑒別子部分，測試重新命名。
Second identification: sub - section added since the substance is used in pharmacies.
第二次鑒別：由于該物質(zhì)在藥房中使用，添加了子部分。
Related substances: grades of solvents amended in accordance with the Technical Guide (2022).
相關(guān)物質(zhì)：溶劑等級已根據(jù)《技術(shù)指南》（2022 年）進(jìn)行修訂。
Amlodipine besilate (1491)
苯磺酸氨氯地平（1491）
Impurity I: new LC procedure to control this additional impurity.
雜質(zhì)I：用于控制這種額外雜質(zhì)的新液相色譜（LC）程序。
Related substances: in the preparation of reference solution (b), volumes expressed using fewer significant figures due to the qualitative use of this solution; grade of methanol amended in accordance with the Technical Guide.
相關(guān)物質(zhì)：在制備對照溶液（b）時(shí)，由于該溶液用于定性，表達(dá)的體積使用較少的有效數(shù)字；甲醇等級已根據(jù)《技術(shù)指南》進(jìn)行修訂。
Aprotinin (0580)
抑肽酶（0580）
Molecular weight: corrected to align with Aprotinin concentrated solution (0579).
分子量：已更正，以與抑肽酶濃縮溶液（0579）一致。
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of anera. Strategy for removal of animal tests for histamine aand depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12-206).
生產(chǎn)：根據(jù)從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及其剩余部分的策略，該部分的一部分已被刪除（見布拉托斯（Bratos M）、科拉伊- 羅賓（Kolaj - Robin O）、安東尼（Antoni M）、沙爾通（Charton E）所著《歐洲藥典：使用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)測試：一個(gè)時(shí)代的終結(jié)。從〈歐洲藥典〉中去除組胺和降壓物質(zhì)動(dòng)物試驗(yàn)及其痕跡的策略》，《歐洲藥典生物科學(xué)札記》，2024 年：12 - 206）。
Aprotinin concentrated solution (0579)
抑肽酶濃縮液（0579）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmaceut Bio Sci Notes. 2024 - 12 - 26).
生產(chǎn)：根據(jù)從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及其殘余的策略，本部分的一部分已被刪除（見Bratos M、Kolaj - Robin O、Antoni M、Charton E.《歐洲藥典》用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)檢測：一個(gè)時(shí)代的結(jié)束。從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及其痕跡的策略。藥物生物科學(xué)注釋，2024 - 12 - 26）。
Bromperidol decanoate (1397)
癸酸溴哌利多（1397）
Related substances: additional experimental verification revealed that the elution order of the late eluting impurities D, K and E was incorrect (impurity D eluting before impurities K and E); impurities specified updated to reflect the quality of substances in approved medicinal products on the European market; system suitability criterion amended to take into account the most critical pairs and the correct elution order of the impurities.
有關(guān)物質(zhì)：額外的實(shí)驗(yàn)驗(yàn)證表明，后期洗脫雜質(zhì)D、K 和E 的洗脫順序不正確（雜質(zhì)D 在雜質(zhì)K 和E 之前洗脫）；更新了規(guī)定的雜質(zhì)，以反映歐洲市場上已批準(zhǔn)藥品中物質(zhì)的質(zhì)量；修改了系統(tǒng)適用性標(biāo)準(zhǔn)，以考慮最關(guān)鍵的雜質(zhì)對和雜質(zhì)的正確洗脫順序。
Assay: colour indicator replaced by potentiometric end - point determination.
含量測定：用電位終點(diǎn)測定法取代顏色指示劑。
Butylhydroxytoluene (0581)
丁基羥基甲苯（0581）
Definition: content limits added.
定義：增加了含量限度。
Characters: solubility in heptane added.
性狀：增加了在庚烷中的溶解性。
Identification: former first identification tests replaced by state - of - the - art analytical procedures (IR and a test cross - referencing the assay); in second identification, the three tests have been replaced by a TLC procedure based on the TLC method originally described for related substances, that can discriminate between butylhydroxytoluene and butylhydroxyanisole.
鑒別：以前的首次鑒別試驗(yàn)被先進(jìn)的分析程序（紅外光譜和與含量測定相關(guān)的一項(xiàng)試驗(yàn)）所取代；在第二次鑒別中，三項(xiàng)試驗(yàn)已被一種基于最初為有關(guān)物質(zhì)所述的薄層色譜法的薄層色譜程序所取代，該程序可以區(qū)分丁基羥基甲苯和丁基羥基茴香醚。
Freezing point: test deleted as it has become obsolete with the introduction of a test for purity based on LC instead of TLC.
冰點(diǎn)：該試驗(yàn)已刪除，因?yàn)殡S著采用基于液相色譜（LC）而非薄層色譜（TLC）的純度試驗(yàn)，該試驗(yàn)已過時(shí)。
Related substances: former TLC method replaced by new UHPLC - UV method covering 11 new impurities.
有關(guān)物質(zhì)：以前的薄層色譜法被新的超高效液相色譜- 紫外檢測法（UHPLC - UV）取代，該方法涵蓋11 種新雜質(zhì)。
Water: test introduced.
水分：引入了檢測項(xiàng)目。
Assay: added.
含量測定：增加。
Impurities: section introduced in accordance with the new test for related substances.
雜質(zhì)：根據(jù)有關(guān)物質(zhì)的新檢測方法引入了該部分。
Charcoal, activated (0313)
活性炭（0313）
Solution S: following deletion of the analytical procedures used for copper, lead and zinc, this solution is no longer needed and has been deleted.
溶液S：在刪除了用于銅、鉛和鋅的分析程序后，該溶液不再需要，已被刪除。
Copper, Lead: in line with the Ph. Eur. implementation strategy for the ICH Q3D guideline on elemental impurities (please see Press release), these tests will be kept with the current limits. In addition, the following impurities will be added: cobalt (5 ppm), nickel (20 ppm) and vanadium (10 ppm); a certain degree of flexibility in the choice of method to be used has been introduced.
銅、鉛：根據(jù)《歐洲藥典》對國際人用藥品注冊技術(shù)協(xié)調(diào)會（ICH）Q3D 元素雜質(zhì)指南的實(shí)施策略（請見新聞稿），這些檢測將保留現(xiàn)行限度。此外，將添加以下雜質(zhì)：鈷（5 ppm）、鎳（20 ppm）和釩（10 ppm）；在方法選擇上引入了一定程度的靈活性。
Zinc: the test will be kept with the current limit and a certain degree of flexibility in the choice of method to be used has been introduced.
鋅：該測試將維持現(xiàn)行限度，并在所用方法的選擇上引入了一定程度的靈活性。
Chymotrypsin (0476)
胰凝乳蛋白酶（0476）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Stratos M. Kolaj - Robin, Antoni M. Chatton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmaceut Bio Sci Notes. 2024:12 - 26).
生產(chǎn)：根據(jù)從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)以及這些試驗(yàn)剩余部分的策略，該部分內(nèi)容已被刪除（見Stratos M. Kolaj - Robin，Antoni M. Chatton，《歐洲藥典》使用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)測試：一個(gè)時(shí)代的結(jié)束。從《歐洲藥典》中去除組胺和降壓物質(zhì)動(dòng)物試驗(yàn)及其痕跡的策略。藥物生物科學(xué)注釋，2024：12 - 26）。
Editorial changes have also been made throughout the monograph. Notably, the description of the colour was updated from purple to reddish - violet as per Style Guide.
在整個(gè)專論中也進(jìn)行了編輯方面的修改。值得注意的是，根據(jù)風(fēng)格指南，顏色描述從紫色更新為紅紫色。
Clomipramine hydrochloride (0889)
鹽酸氯米帕明（0889）
First identification: tests relabelled due to addition of the second identification sub - section.
首次鑒別：由于增加了第二個(gè)鑒別子部分，對測試進(jìn)行了重新標(biāo)記。
Second identification: sub - section added since the substance is used in pharmacies.
二次鑒別：由于該物質(zhì)在藥房中使用，增加了子部分。
Related substances: reagent used to describe the stationary phase modified; grade of water in the mobile phase amended in accordance with the Technical Guide (2022); in the preparation of reference solution (c), volume and mass expressed using fewer significant figures due to the qualitative use of this solution.
有關(guān)物質(zhì)：用于描述固定相的試劑已修改；流動(dòng)相中的水的級別已根據(jù)《技術(shù)指南》（2022 年）進(jìn)行修訂；在制備對照溶液（c）時(shí)，由于該溶液為定性使用，體積和質(zhì)量用較少的有效數(shù)字表示。
Clonazepam (0890)
氯硝西泮（0890）
Identification by IR: use of a reference standard as an alternative to reference spectrum.
紅外鑒別：使用參比標(biāo)準(zhǔn)品作為參比光譜的替代方法。
Related substances: impurities specifications updated to reflect the quality of substances in approved medicinal products on the European market; only impurity B is now specified at 0.10%; the system suitability criterion has been modified to avoid the use of an external compound.
有關(guān)物質(zhì)：雜質(zhì)規(guī)范已更新，以反映歐洲市場上已批準(zhǔn)藥品中物質(zhì)的質(zhì)量；現(xiàn)在僅規(guī)定雜質(zhì)B 為0.10%；系統(tǒng)適用性標(biāo)準(zhǔn)已修改，以避免使用外部化合物。
Clopidogrel besilate (2790)
硫酸氫氯吡格雷（2790）
Identification: the ratio between the peaks due to besilate and clopidogrel in test D has been deleted, as the main peak has been found to be outside the linear range of the UV - detector. The requirement for similar retention time of the peaks due to besilate in test and reference solutions has been sufficient to properly identify the besilate ions.
鑒別：測試D 中硫酸根和氯吡格雷峰之間的比率已被刪除，因?yàn)榘l(fā)現(xiàn)主峰超出了紫外檢測器的線性范圍。測試溶液和對照溶液中硫酸根峰的保留時(shí)間相似這一要求已足以正確鑒別硫酸根離子。
Enantiomeric purity: in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution.
對映體純度：在制備對照溶液（a）時(shí)，由于該溶液為定性使用，體積用較少的有效數(shù)字表示。
Related substances: in the preparation of reference solutions (b) and (d), volume expressed using fewer significant figures due to the qualitative use of this solution.
有關(guān)物質(zhì)：在制備對照溶液（b）和（d）時(shí)，由于該溶液為定性使用，體積用較少的有效數(shù)字表示。
Clopidogrel hydrogen sulfate (2531)
硫酸氫氯吡格雷（2531）
Enantiomeric purity: in the preparation of test solution, mass expressed using more significant figures for better accuracy; calculation method updated to reflect the manufacturer's approach; system suitability test updated for the signal - to - noise ratio to verify the sensitivity of the procedure.
對映體純度：在制備供試溶液時(shí)，為了更高的準(zhǔn)確性，質(zhì)量用更多的有效數(shù)字表示；計(jì)算方法已更新以反映制造商的方法；系統(tǒng)適用性測試已針對信噪比進(jìn)行更新，以驗(yàn)證該程序的靈敏度。
Related substances: in the preparation of test solution, mass expressed using more significant figures for better accuracy.
有關(guān)物質(zhì)：在制備供試溶液時(shí)，為了更高的準(zhǔn)確性，質(zhì)量用更多的有效數(shù)字表示。
Codergocrine mesilate (2060)
甲磺酸雙氫麥角毒堿（2060）
Assay: for the calculation of codergocrine mesilate content, correction factors updated to better reflect the difference in absorption coefficient between dihydroergocristine mesilate and the 3 other components.
含量測定：為計(jì)算甲磺酸雙氫麥角毒堿的含量，更新了校正因子，以更好地反映甲磺酸雙氫麥角汀與其他3 種成分在吸收系數(shù)上的差異。
Danaparoid sodium (2090)
達(dá)那肝素鈉（2090）
Structural formula: modified to simplify labelling of substituents (from R1 - 6 to R and R').
結(jié)構(gòu)式：進(jìn)行了修改，以簡化取代基的標(biāo)記（從R1 - 6 改為R 和R'）。
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12 - 26).
生產(chǎn)：根據(jù)從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及這些試驗(yàn)剩余部分的策略，該部分內(nèi)容已被刪除（見Bratos M, Kolaj - Robin O, Antoni M, Charton E.《歐洲藥典》用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)檢測：一個(gè)時(shí)代的終結(jié)。從《歐洲藥典》中去除組胺和降壓物質(zhì)動(dòng)物試驗(yàn)及其痕跡的策略。Pharmeur 生物科學(xué)筆記。2024:12 - 26）。
The sentence referring to minimising or eliminating endotoxins has also been deleted. This aspect is addressed in the Tests section.
提及盡量減少或消除內(nèi)毒素的句子也已被刪除。這方面內(nèi)容在 “檢測” 部分闡述。
Daunorubicin hydrochloride (0662)
鹽酸柔紅霉素（0662）
Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12 - 26).
生產(chǎn)：根據(jù)從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及這些試驗(yàn)剩余部分的策略，該部分內(nèi)容已被刪除（見Bratos M, Kolaj - Robin O, Antoni M, Charton E.《歐洲藥典》用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)檢測：一個(gè)時(shí)代的終結(jié)。從《歐洲藥典》中去除組胺和降壓物質(zhì)動(dòng)物試驗(yàn)及其痕跡的策略。Pharmeur 生物科學(xué)筆記。2024:12 - 26）。
Dicloxacillin sodium (0663)
雙氯西林鈉（0663）
Production: as some manufacturers may choose not to use N,N - dimethylaniline in their production process anymore, the presence of this impurity is now controlled using a risk - based approach. As this aspect cannot always be verified by an independent analyst, the requirement for testing N,N - dimethylaniline has been removed from the Tests section and a Production option has been introduced.
生產(chǎn)：由于一些制造商可能不再選擇在生產(chǎn)過程中使用N,N - 二甲基苯胺，現(xiàn)在使用基于風(fēng)險(xiǎn)的方法控制這種雜質(zhì)的存在。由于這方面內(nèi)容不能總是由獨(dú)立分析師驗(yàn)證，檢測N,N - 二甲基苯胺的要求已從 “檢測” 部分刪除，并引入了一個(gè)生產(chǎn)選項(xiàng)。
Specific optical rotation: the test has been removed as the quality is adequately controlled with the improved method for related substances.
比旋度：該檢測已被刪除，因?yàn)橄嚓P(guān)物質(zhì)的改進(jìn)方法已能充分控制質(zhì)量。
Related substances: an improved LC method is proposed with limits based on the quality of the substance used in the manufacture of currently approved products.
有關(guān)物質(zhì)：提出了一種改進(jìn)的液相色譜（LC）方法，其限度基于目前已批準(zhǔn)產(chǎn)品生產(chǎn)中所用物質(zhì)的質(zhì)量。
N,N - dimethylaniline: see Production section above.
N,N - 二甲基苯胺：見上文 “生產(chǎn)” 部分。
Assay: a revised method has been introduced based on the improved LC method used for related substances.
含量測定：基于用于有關(guān)物質(zhì)的改進(jìn)液相色譜方法，引入了一種修訂的方法。
Impurities: additional impurities have been included and structures modified based on currently available data.
雜質(zhì)：根據(jù)目前可用的數(shù)據(jù)，納入了額外的雜質(zhì)并修改了結(jié)構(gòu)。
Dosulepin hydrochloride (1314)
鹽酸多塞平（1314）
First identification: tests relabelled due to changes in the second identification.
首次鑒別：由于第二次鑒別的變化，對檢測進(jìn)行了重新標(biāo)記。
Second identification: former test A (by UV) deleted since not feasible in pharmacies; former test C (colour reaction) deleted as considered superfluous; new double detection introduced.
二次鑒別：先前的測試A（通過紫外線）因在藥房不可行而刪除；先前的測試C（顏色反應(yīng)）因被認(rèn)為多余而刪除；引入了新的雙重檢測。
Escitalopram (2758)
艾司西酞普蘭（2758）
Related substances: grades of solvents amended in accordance with the Technical Guide; in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution.
有關(guān)物質(zhì)：溶劑等級根據(jù)技術(shù)指南進(jìn)行了修訂；在制備測試溶液時(shí)，為了更高的準(zhǔn)確性，質(zhì)量用更多有效數(shù)字表示；在制備對照溶液（a）時(shí)，由于該溶液的定性用途，體積用較少的有效數(shù)字表示。
Enantiomeric purity: grades of solvents amended in accordance with the Technical Guide; in the preparation of reference solution (a), mass and volumes expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer’s approach; reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.
對映體純度：溶劑等級根據(jù)技術(shù)指南進(jìn)行了修訂；在制備對照溶液（a）時(shí)，由于該溶液的定性用途，質(zhì)量和體積用較少的有效數(shù)字表示；計(jì)算方法更新以反映制造商的方法；報(bào)告閾值被額外的系統(tǒng)適用性測試（最小信噪比）取代，以驗(yàn)證該程序的靈敏度。
Escitalopram oxalate (2733)
草酸艾司西酞普蘭（2733）
Related substances: grades of solvents amended in accordance with the Technical Guide; in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution.
有關(guān)物質(zhì)：溶劑等級根據(jù)技術(shù)指南進(jìn)行了修訂；在制備測試溶液時(shí)，為了更高的準(zhǔn)確性，質(zhì)量用更多有效數(shù)字表示；在制備對照溶液（a）時(shí)，由于該溶液的定性用途，體積用較少的有效數(shù)字表示。
Enantiomeric purity: grades of solvents amended in accordance with the Technical Guide; in the preparation of reference solution (a), mass and volumes expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer’s approach; reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.
對映體純度：溶劑等級根據(jù)技術(shù)指南進(jìn)行了修訂；在制備對照溶液（a）時(shí)，由于該溶液的定性用途，質(zhì)量和體積用較少的有效數(shù)字表示；計(jì)算方法更新以反映制造商的方法；報(bào)告閾值被額外的系統(tǒng)適用性測試（最小信噪比）取代，以驗(yàn)證該程序的靈敏度。
Esomeprazole magnesium dihydrate (2787)
埃索美拉唑鎂二水合物（2787）
Enantiomeric purity: grades of solvents amended in accordance with the Technical Guide; in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solution (a), volumes expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer’s approach; system suitability test introduced for the signal - to - noise ratio to verify the sensitivity of the procedure.
對映體純度：溶劑等級根據(jù)技術(shù)指南進(jìn)行了修訂；在制備測試溶液時(shí)，為了更高的準(zhǔn)確性，質(zhì)量用更多有效數(shù)字表示；在制備對照溶液（a）時(shí)，由于該溶液的定性用途，體積用較少的有效數(shù)字表示；計(jì)算方法更新以反映制造商的方法；引入了針對信噪比的系統(tǒng)適用性測試，以驗(yàn)證該程序的靈敏度。
Related substances: in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solutions (a) and (b), volumes expressed using fewer significant figures due to the qualitative use of these solutions.
有關(guān)物質(zhì)：在制備測試溶液時(shí)，為了更高的準(zhǔn)確性，質(zhì)量用更多有效數(shù)字表示；在制備對照溶液（a）和（b）時(shí)，由于這些溶液的定性用途，體積用較少的有效數(shù)字表示。
Esomeprazole magnesium trihydrate (2372)
埃索美拉唑鎂三水合物（2372）
Enantiomeric purity: grades of solvents amended in accordance with the Technical Guide; in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solution (a), volumes expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer’s approach; system suitability test introduced for the signal - to - noise ratio to verify the sensitivity of the procedure.
對映體純度：溶劑等級根據(jù)技術(shù)指南進(jìn)行了修訂；在制備測試溶液時(shí)，為了更高的準(zhǔn)確性，質(zhì)量用更多有效數(shù)字表示；在制備對照溶液（a）時(shí)，由于該溶液的定性用途，體積用較少的有效數(shù)字表示；計(jì)算方法更新以反映制造商的方法；引入了針對信噪比的系統(tǒng)適用性測試，以驗(yàn)證該程序的靈敏度。
Related substances: in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solutions (a) and (b), volumes expressed using fewer significant figures due to the qualitative use of these solutions.
相關(guān)物質(zhì)：在制備供試溶液時(shí)，為提高準(zhǔn)確度，質(zhì)量的表示使用更多有效數(shù)字；在制備對照溶液(a) 和(b) 時(shí)，由于這些溶液用于定性，體積的表示使用較少的有效數(shù)字。
Esomeprazole sodium (2923)
埃索美拉唑鈉（2923）
Enantiomeric purity: in the preparation of the test solution, mass expressed using more significant figures for better accuracy; calculation method updated to reflect the manufacturer's approach; reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.
對映體純度：在制備供試液時(shí)，為提高準(zhǔn)確性，使用更多有效數(shù)字表示質(zhì)量；更新計(jì)算方法以反映制造商的方法；用額外的系統(tǒng)適用性試驗(yàn)（最低信噪比）取代報(bào)告閾值，以驗(yàn)證該程序的靈敏度。
Related substances: in the preparation of the test solution, mass expressed using more significant figures for better accuracy.
有關(guān)物質(zhì)：在制備供試液時(shí)，為提高準(zhǔn)確性，使用更多有效數(shù)字表示質(zhì)量。
Fluconazole (2287)
氟康唑（2287）
Related substances: the quantitative style has been introduced; limits for impurities B and C were updated to reflect the quality of the substances in approved medicinal products on the European market; the description of the stationary phase has been amended.
有關(guān)物質(zhì)：引入了定量方式；更新了雜質(zhì)B 和C 的限度，以反映歐洲市場上已批準(zhǔn)藥品中物質(zhì)的質(zhì)量；修改了固定相的描述。
Fluticasone propionate (1750)
丙酸氟替卡松（1750）
Related substances: the description of reference solution (c) has been changed due to a change in the preparation of the CRS for system suitability.
有關(guān)物質(zhì)：由于系統(tǒng)適用性用對照品溶液（CRS）制備方法的改變，對照溶液（c）的描述已更改。
Follitropin (2285)
促卵泡生成素（2285）
Assay: the procedure has been modified to remove the mercury - containing compound thiomersal (REACH) as an example of a suitable antimicrobial preservative.
含量測定：已修改程序，以去除含汞化合物硫柳汞（REACH 法規(guī)相關(guān)）作為合適的抗菌防腐劑示例。
Follitropin concentrated solution (2286)
促卵泡生成素濃縮溶液（2286）
Assay: the procedure has been modified to remove the mercury - containing compound thiomersal (REACH) as an example of a suitable antimicrobial preservative.
含量測定：已修改程序，以去除含汞化合物硫柳汞（REACH 法規(guī)相關(guān)）作為合適的抗菌防腐劑示例。
Glycerol dibehenate (1427)
二山崳酸甘油酯（1427）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.
含量測定：柱直徑從7 毫米改為7.5 毫米。直徑為7 毫米的色譜柱不再生產(chǎn)。
Glycerol distearate (1428)
二硬脂酸甘油酯（1428）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.
含量測定：柱直徑從7 毫米改為7.5 毫米。直徑為7 毫米的色譜柱不再生產(chǎn)。
Glycerol monolaurate (1429)
單月桂酸甘油酯（1429）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.
含量測定：柱直徑從7 毫米改為7.5 毫米。直徑為7 毫米的色譜柱不再生產(chǎn)。
Glycerol mono - oleate (1430)
單油酸甘油酯（1430）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.
含量測定：柱直徑從7 毫米改為7.5 毫米。直徑為7 毫米的色譜柱不再生產(chǎn)。
Glycerol monostearate 40 - 55 (0495)
單硬脂酸甘油酯40 - 55（0495）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.
測定：柱直徑從7 毫米變?yōu)?.5 毫米。直徑為7 毫米的柱子不再生產(chǎn)。
Gonadotrophin, chorionic (0498)
絨毛膜促性腺激素（0498）
Assay: the procedure has been modified to remove the mercury - containing compound thiomersal (REACH) as an example of a suitable antimicrobial preservative.
測定：該程序已被修改，以去除含汞化合物硫柳汞（REACH），作為合適的抗菌防腐劑的一個(gè)例子。
Haemodialysis, concentrated solutions for (3206)
血液透析濃縮液（3206）
This monograph has been elaborated specifically for concentrated solutions for haemodialysis because they are no longer covered by monograph 0128 which, subsequent to its proposed revision, now describes requirements for final solutions for haemodialysis only.
本專論專門針對血液透析濃縮液進(jìn)行了闡述，因?yàn)樗鼈儾辉儆?128 專論涵蓋，0128 專論在其提議修訂后，現(xiàn)在僅描述了血液透析最終溶液的要求。
Haemodialysis, solutions, concentrated, water for diluting (1167)
血液透析濃縮溶液，稀釋用水（1167）
The monograph has been revised to reflect current practices and to align with the water monographs (Water, purified (0008) and Water for injections (0169)).
該專論已被修訂，以反映當(dāng)前的實(shí)踐，并與水專論（純化水（0008）和注射用水（0169））保持一致。
-Definition section: updated to clearly define how the preparation / solution is prepared.
-定義部分：已更新，以明確界定制劑/ 溶液的制備方法。
-Production section: added:
-生產(chǎn)部分：增加了：
-Use of both potable water and water prepared by ion exchange or distillation no longer described to reflect most common current practices.
-不再描述使用飲用水以及通過離子交換或蒸餾制備的水，以反映當(dāng)前最常見的做法。
-Paragraph on the “surveillance of the quality of water... and analytical methods”moved to the Tests section.
-關(guān)于 “水質(zhì)量監(jiān)測…… 和分析方法” 的段落已移至測試部分。
-Microbial contamination test renamed “Microbiological monitoring”and moved from Tests section to Production section. The R2A agar test procedure is described and includes the following parameters: medium, time and temperature, as well as preparation of test strains and growth promotion of R2A agar.
-微生物污染測試更名為 “微生物監(jiān)測”，并從測試部分移至生產(chǎn)部分。描述了R2A 瓊脂測試程序，包括以下參數(shù)：培養(yǎng)基、時(shí)間和溫度，以及測試菌株的制備和R2A 瓊脂的促生長。
-Tests section:
-測試部分：
-Aluminium: replaced by a more state - of - the - art method which is already included in the other dialysis monographs.
-鋁：被一種更先進(jìn)的方法所取代，該方法已包含在其他透析專論中。
-Heavy metals: Heavy metals test (2.4.8) removed and replaced by an Other elemental impurities test describing the individual metal tests (copper and lead, with applicable limits, and additional elemental impurities) based on a risk assessment approach.
-重金屬：重金屬測試（2.4.8）已被移除，取而代之的是其他元素雜質(zhì)測試，該測試基于風(fēng)險(xiǎn)評估方法描述了單個(gè)金屬測試（銅和鉛，以及適用的限度，和其他元素雜質(zhì)）。
Bacterial endotoxins: the text now allows the use of the recombinant factor C (rFC) test for the control of bacterial endotoxins.
細(xì)菌內(nèi)毒素：文本現(xiàn)在允許使用重組C 因子（rFC）測試來控制細(xì)菌內(nèi)毒素。
Haemodialysis, solutions for (0128)
血液透析溶液（0128）
The previous version of this monograph described both concentrated and final solutions for haemodialysis. The revised monograph focuses exclusively on final solutions. Consequently, major changes have been made to the Definition, Tests and Labelling sections.
本專論的先前版本描述了血液透析的濃縮溶液和最終溶液。修訂后的專論僅關(guān)注最終溶液。因此，對定義、測試和標(biāo)簽部分進(jìn)行了重大修改。
-Definition section:
-定義部分：
-Updated to cover both solutions prepared on - line and provided in containers.
-已更新，以涵蓋在線制備和容器中提供的溶液。
-Formulation composition tables: addition of the use of citrate and citric/lactic acids and correction of the concentration range (potassium, acids) to reflect the current products on the market.
-配方組成表：添加檸檬酸鹽和檸檬酸/ 乳酸的使用情況，并修正濃度范圍（鉀、酸）以反映市場上的現(xiàn)有產(chǎn)品。
-Addition of a statement about the use of antioxidants.
-添加關(guān)于抗氧化劑使用的說明。
-Identification section: addition of citrates.
-鑒別部分：添加檸檬酸鹽。
-Tests section:
-測試部分：
-Inclusion of new tests (pH, Hydroxymethylfurfural, Particulate contamination and Citrate).
-納入新的測試項(xiàng)目（pH、羥甲基糠醛、顆粒污染和檸檬酸鹽）。
-Lactate and hydrogen carbonate assay has been added to offer possibility to perform both tests simultaneously in alignment with monograph 0861.
-已添加乳酸鹽和碳酸氫鹽測定法，以便能夠根據(jù)專論0861 同時(shí)進(jìn)行這兩項(xiàng)測試。
-Assay section: inclusion of the citrate assay.
-含量測定部分：納入檸檬酸鹽測定法。
Haemofiltration and haemodiafiltration, concentrated solutions for (2770)
血液濾過和血液透析濾過用濃縮液（2770）
The monograph has been revised to reflect current practices and to align it with other dialysis monographs (i.e. 0128, 0861, 0862).
該專論已修訂，以反映當(dāng)前的實(shí)踐，并使其與其他透析專論（即0128、0861、0862）保持一致。
-Definition section:
-定義部分：
-Addition of a definition of the final and ready - to - use solutions.
-添加最終和即用型溶液的定義。
-Addition of a statement about the three types of concentrated solutions used.
-添加關(guān)于所使用的三種濃縮溶液的說明。
-Removal of the table giving the composition of the concentrated formulations and making reference to Haemofiltration and haemodiafiltration, solutions for (0861).
-刪除給出濃縮配方組成的表格，并提及血液濾過和血液透析濾過用溶液（0861）。
-Removal of the statement on the use of hydrogen carbonate, which does not apply to haemofiltration and haemodiafiltration.
-刪除關(guān)于碳酸氫鹽使用的說明，該說明不適用于血液濾過和血液透析濾過。
-Clarification for the statement about the use of antioxidants.
-對關(guān)于抗氧化劑使用的說明進(jìn)行澄清。
-Identification section: removal of carbonates and hydrogen carbonates, which is specific to ready - to - use haemofiltration and haemodiafiltration solutions.
-鑒別部分：刪除即用型血液濾過和血液透析濾過溶液特有的碳酸鹽和碳酸氫鹽。
-Tests section:
-測試部分：
-pH: addition of clarification that the limits apply to ready - to - use solutions; adding new limits when the solution contains hydrogen carbonate.-pH：
添加說明，限值適用于即用型溶液；當(dāng)溶液含有碳酸氫鹽時(shí)添加新的限值。
-Aluminium: addition of clarification that the limit applies to final solutions.
-鋁：添加說明，限值適用于最終溶液。
-Hydroxymethylfurfural: clarification that this test applies when the preparation contains glucose and is heat - sterilised.
-羥甲基糠醛：澄清當(dāng)制劑含有葡萄糖并經(jīng)過熱滅菌時(shí)適用此測試。
-Microbial contamination: inclusion of new test parameter when the preparation is not claimed to be sterile.
-微生物污染：當(dāng)制劑未聲稱無菌時(shí)，納入新的測試參數(shù)。
-Pyrogenicity: addition of new test in accordance with the new requirement in general chapter 5.1.13.
-熱原性：根據(jù)通則5.1.13 中的新要求添加新測試。
Haemofiltration and haemodiafiltration, solutions for (0861)血液濾過和血液透析濾過用溶液（0861）
The monograph has been revised to reflect current practices and align with the other dialysis monographs (i.e. 0128, 0862 and 2770).
該專論已修訂，以反映當(dāng)前的實(shí)踐，并與其他透析專論（即0128、0862 和2770）保持一致。
-Definition section:
-定義部分：
-Addition of a statement on the on - line preparation by diluting concentrated solutions and clarification between the on - line preparations and ready - to - use preparations/solutions.
-添加關(guān)于通過稀釋濃縮溶液進(jìn)行在線制備以及在線制劑和即用制劑/ 溶液之間澄清的說明。
-Addition of a statement on the use of antioxidants.
-添加關(guān)于抗氧化劑使用的說明。
-Formulation compositions table: addition of the use of citrate/citric acid.
-配方組成表：添加檸檬酸鹽/ 檸檬酸的使用說明。
-Identification section: Addition of citrates since citrate has been added as a component of the haemofiltration and haemodiafiltration preparations.
-鑒別部分：添加檸檬酸鹽，因?yàn)闄幟仕猁}已作為血液濾過和血液透析濾過制劑的一種成分添加。
-Tests section:
-測試部分：
-Hydroxymethylfurfural: addition of the clarification that this test applies when (a) the solution is provided in containers, contains glucose and is heat - sterilised, or (b) the solution is prepared on - line and is produced from heat - sterilised concentrates containing glucose.
-羥甲基糠醛：添加說明，當(dāng)（a）溶液裝在容器中，含有葡萄糖并經(jīng)過熱滅菌，或（b）溶液在線制備且由含有葡萄糖的熱滅菌濃縮物生產(chǎn)時(shí)，適用此測試。
-Extractable volume: addition of clarification that this test applies to solutions packaged in containers.
-可提取體積：添加說明，此測試適用于裝在容器中的溶液。
-Assay section: inclusion of the citrate assay since citrate has been added as a component of the haemofiltration and haemodiafiltration preparations.
-含量測定部分：納入檸檬酸鹽含量測定，因?yàn)闄幟仕猁}已作為血液濾過和血液透析濾過制劑的一種成分添加。
-Labelling section: addition of the requirement that the haemofiltration and haemodiafiltration solution is sterile.
-標(biāo)簽部分：添加血液濾過和血液透析濾過溶液必須無菌的要求。
Hard fat (0462)
硬脂（0462）
Hydroxyl value: possibility of performing the titration on a warmed solution introduced to avoid potential congealing.
羥值：可以對溫?zé)岬娜芤哼M(jìn)行滴定，以避免潛在的凝結(jié)。
Hard fat with additives (2731)
含添加劑的硬脂（2731）
Hydroxyl value: possibility of performing the titration on a warmed solution introduced to avoid potential congealing.
羥值：可以對溫?zé)岬娜芤哼M(jìn)行滴定，以避免潛在的凝結(jié)。
Heparin calcium (0332)
肝素鈣（0332）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia, (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmacopoeia Bio Sci Notes. 2024:12 - 26).
生產(chǎn)：根據(jù)從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)以及這些試驗(yàn)剩余部分的策略，該部分的一部分已被刪除（見Bratos M、Kolaj - Robin O、Antoni M、Charton E.《歐洲藥典》用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)測試：一個(gè)時(shí)代的結(jié)束。從《歐洲藥典》中去除組胺和降壓物質(zhì)動(dòng)物試驗(yàn)及其痕跡的策略。藥典生物科學(xué)筆記，2024：12 - 26）。
Heparin sodium (0333)肝素鈉（0333）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmacopoeia Bio Sci Notes. 2024:12 - 26).
生產(chǎn)：根據(jù)從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)以及這些試驗(yàn)剩余部分的策略，該部分的一部分已被刪除（見Bratos M、Kolaj - Robin O、Antoni M、Charton E.《歐洲藥典》用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)測試：一個(gè)時(shí)代的結(jié)束。從《歐洲藥典》中去除組胺和降壓物質(zhì)動(dòng)物試驗(yàn)及其痕跡的策略。藥典生物科學(xué)筆記，2024：12 - 26）。
Heparins, low - molecular - mass (0828)
低分子量肝素（0828）
Identification C: the preparation of the reference solution was adapted taking into account the amount of heparin low - molecular - mass for calibration CRS 6 per vial.
鑒別C：參考溶液的制備考慮了每瓶用于校準(zhǔn)的低分子量肝素對照品6 的量進(jìn)行了調(diào)整。
Homatropine hydrobromide (0500)
氫溴酸后馬托品（0500）
Characters: melting point deleted.
性狀：熔點(diǎn)刪除。
Related substances: grades of solvents amended in accordance with the Technical Guide;
有關(guān)物質(zhì)：溶劑等級根據(jù)技術(shù)指南進(jìn)行了修訂；
in the preparation of reference solution (b), volume expressed using fewer significant figures due to qualitative use of this solution; requirement for the symmetry factor deleted;
在制備對照溶液（b）時(shí)，由于該溶液為定性使用，體積以較少的有效數(shù)字表示；對稱因子的要求刪除；
quantitative style now prescribed; introduction of a limit at 0.10 per cent for unspecified impurities; impurity limits updated to reflect current quality of the products on the market;
現(xiàn)在規(guī)定了定量方式；引入了未指定雜質(zhì)0.10% 的限度；雜質(zhì)限度進(jìn)行了更新以反映市場上產(chǎn)品的當(dāng)前質(zhì)量；
impurities A, B, C and D listed as unspecified impurities; limit for total impurities tightened from 1.0 per cent to 0.5 per cent.
雜質(zhì)A、B、C 和D 列為未指定雜質(zhì)；總雜質(zhì)限度從1.0% 收緊至0.5%。
Hydroxyethylcellulose (0336)
羥乙基纖維素（0336）
Functionality - related characteristics: the section has been revised to add, in addition to its use as a viscosity - increasing agent, the following characteristics that may be considered critical and useful material attributes when hydroxyethylcellulose is used as a matrix former for modified - release solid dosage forms: viscosity and molar substitution (cross - references);
功能性相關(guān)特性：該部分已修訂，除了其作為增粘劑的用途外，當(dāng)羥乙基纖維素用作緩釋固體劑型的基質(zhì)形成劑時(shí)，還添加了以下可被視為關(guān)鍵且有用的材料屬性：粘度和摩爾取代度（相互參照）；
molecular - mass distribution, particle - size distribution and powder flow (references to Ph. Eur. general chapters). The term 'degree of substitution' has been replaced by'molar substitution'.
分子量分布、粒度分布和粉末流動(dòng)性（參考?xì)W洲藥典通則）。“取代度” 一詞已被 “摩爾取代度” 取代。
The entire non - mandatory Functionality - related characteristics section is marked with white diamonds to indicate its status as a local Ph. Eur. requirement of this PDG harmonised monograph.
整個(gè)非強(qiáng)制性的功能性相關(guān)特性部分用白色菱形標(biāo)記，以表明其作為本PDG 協(xié)調(diào)專論的歐洲藥典地方要求的地位。
Hydroxypropyl cellulose, low - substituted (2083)
低取代羥丙基纖維素（2083）
Assay: calculation updated to align with the PDG sign - off text.
含量測定：計(jì)算方法更新以與PDG 批準(zhǔn)文本一致。
Hypromellose (0348)
羥丙甲纖維素（0348）
Assay: calculation updated to align with the PDG sign - off text.
含量測定：計(jì)算方法更新以與 PDG 批準(zhǔn)文本一致。
Indometacin (0092)
吲哚美辛（0092）
Characters: solubility in heptane added.
性狀：增加了在庚烷中的溶解性。
Related substances: concentration of formic acid in mobile phases A and B corrected in accordance with the procedure as originally validated during elaboration of the monograph.
有關(guān)物質(zhì)：流動(dòng)相A 和B 中甲酸的濃度根據(jù)在制定該專論時(shí)最初驗(yàn)證的程序進(jìn)行了校正。
Assay: concentration of acetic acid in mobile phases A and B corrected by referring to the right reagent, thus in accordance with the procedure as originally validated during elaboration of the monograph.
含量測定：流動(dòng)相A 和B 中乙酸的濃度通過參考正確的試劑進(jìn)行了校正，因此符合在制定該專論時(shí)最初驗(yàn)證的程序。
Kanamycin sulfate (0033)
硫酸卡那霉素（0033）
Formula: the chemical structure has been introduced.
分子式：引入了化學(xué)結(jié)構(gòu)。
Definition: the chemical nomenclature has been introduced. The definition now shows that the substance contains a variable quantity of sulfuric acid and water, and that it is produced from kanamycin monosulfate hydrate.
定義：引入了化學(xué)命名法。現(xiàn)在的定義表明該物質(zhì)含有可變數(shù)量的硫酸和水，并且它是由硫酸卡那霉素一水合物生產(chǎn)的。
Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M., Kolaj - Robin O., Antoni M., Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depresssor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12-26).
生產(chǎn)：根據(jù)從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)以及這些試驗(yàn)剩余部分的策略，該部分已被刪除（見布拉托斯（Bratos M.）、科拉伊- 羅賓（Kolaj - Robin O.）、安東尼（Antoni M.）、沙爾通（Charton E.）所著《歐洲藥典使用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)測試：一個(gè)時(shí)代的終結(jié)。從〈歐洲藥典〉中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及其痕跡的策略》，《歐洲藥典生物科學(xué)通訊》，2024 年：12 - 26 頁）。
Kanamycin monosulfate monohydrate (0032)
硫酸卡那霉素單水合物（0032）
Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj-Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmer Bio Sci Notes. 2024;12 - 26).
生產(chǎn)：根據(jù)從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及其殘余的策略，該部分已被刪除（見Bratos M、Kolaj - Robin O、Antoni M、Charton E.《歐洲藥典》使用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)檢測：一個(gè)時(shí)代的結(jié)束。從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及其痕跡的策略。Pharmer 生物科學(xué)筆記，2024 年；12 - 26）。
Lacosamide (292)
拉科酰胺（292）
Enantiomeric purity: in the preparation of reference solutions (a) and (b), volumes expressed using fewer significant figures due to the qualitative use of these solutions; calculation method updated to reflect the manufacturer's approach; reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.
對映體純度：在制備對照溶液（a）和（b）時(shí)，由于這些溶液的定性使用，體積用較少的有效數(shù)字表示；計(jì)算方法已更新以反映制造商的方法；報(bào)告閾值被額外的系統(tǒng)適用性測試（最小信噪比）取代，以驗(yàn)證該程序的靈敏度。
Related substances: in the preparation of reference solutions (c) and (d), volumes expressed using fewer significant figures due to the qualitative use of these solutions.
有關(guān)物質(zhì)：在制備對照溶液（c）和（d）時(shí)，由于這些溶液的定性使用，體積用較少的有效數(shù)字表示。
Lamivudine (2217)
拉米夫定（2217）
Enantiomeric purity: in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer's approach; system suitability test introduced for the signal - to - noise ratio to verify the sensitivity of the procedure.
對映體純度：在制備對照溶液（a）時(shí)，由于該溶液的定性使用，體積用較少的有效數(shù)字表示；計(jì)算方法已更新以反映制造商的方法；引入了信噪比系統(tǒng)適用性測試以驗(yàn)證該程序的靈敏度。
Impurities
雜質(zhì)
Levetiracetam (2535)
左乙拉西坦（2535）
Enantiomeric purity: in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer's approach; reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.
對映體純度：在制備對照溶液（a）時(shí)，由于該溶液的定性使用，體積用較少的有效數(shù)字表示；計(jì)算方法已更新以反映制造商的方法；報(bào)告閾值被額外的系統(tǒng)適用性測試（最小信噪比）取代，以驗(yàn)證該程序的靈敏度。
Impurity G: in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of the test solution (c), volumes expressed using fewer significant figures due to the qualitative use of this solution.
雜質(zhì)G：在制備供試溶液時(shí)，為了更高的準(zhǔn)確性，質(zhì)量用更多的有效數(shù)字表示；在制備供試溶液（c）時(shí)，由于該溶液的定性使用，體積用較少的有效數(shù)字表示。
Related substances: in the preparation of reference solution (a), volumes expressed using fewer significant figures due to the qualitative use of this solution.
有關(guān)物質(zhì)：在制備對照溶液（a）時(shí)，由于該溶液的定性使用，體積用較少的有效數(shù)字表示。
Macrogols (1444)
聚乙二醇（1444）
Functionality - related characteristics: the section has been revised to add, in addition to its use as a solvent, stabiliser, lubricant, thickener and base, the following characteristics that may be considered critical and useful material attributes: macrogols are used as a binder and as a matrix former for modified - release solid dosage forms.
功能性相關(guān)特性：該部分已修訂，除了其作為溶劑、穩(wěn)定劑、潤滑劑、增稠劑和基質(zhì)的用途外，還添加了以下可能被視為關(guān)鍵且有用的材料屬性：聚乙二醇用作粘合劑和用于緩釋固體劑型的基質(zhì)形成劑。
-for macrogols used as binder: viscosity (cross - reference);
-對于用作粘合劑的聚乙二醇：粘度（相互參照）；
-for macrogols used as a matrix former for modified - release solid dosage forms: viscosity (cross - reference); molecular mass distribution, particle - size distribution and powder flow (references to Ph. Eur. general chapters).
-對于用作緩釋固體劑型基質(zhì)形成劑的聚乙二醇：粘度（交叉引用）；分子量分布、粒度分布和粉末流動(dòng)性（參考?xì)W洲藥典通則章節(jié)）。
Few editorial changes have also been made throughout the monograph to align with the current style guide.
在整個(gè)專論中也進(jìn)行了一些編輯上的更改，以符合當(dāng)前的風(fēng)格指南。
Macrogols, high - molecular - mass (2444)
高分子量聚乙二醇（2444）
Functionality - related characteristics: a section has been added to introduce characteristics that may be considered critical and useful material attributes when high - molecular mass macrogols are used as a binder and as a matrix former for modified - release solid dosage forms:
與功能相關(guān)的特性：添加了一個(gè)部分，以介紹當(dāng)高分子量聚乙二醇用作粘合劑和緩釋固體劑型的基質(zhì)形成劑時(shí)，可能被視為關(guān)鍵且有用的材料屬性：
for high - molecular - mass macrogols used as a binder: viscosity (cross - reference);
對于用作粘合劑的高分子量聚乙二醇：粘度（交叉引用）；
for high - molecular - mass macrogols used as a matrix former for modified - release solid dosage forms: viscosity (cross - reference); molecular mass distribution, particle - size distribution and powder flow (references to Ph. Eur. general chapters).
對于用作緩釋固體劑型基質(zhì)形成劑的高分子量聚乙二醇：粘度（交叉引用）；分子量分布、粒度分布和粉末流動(dòng)性（參考?xì)W洲藥典通則章節(jié)）。
Maize starch (0344)玉米淀粉（0344）
This draft corresponds to Revision 4, Stage 2 (based on the Pharmacopoeial Discussion Group (PDG) working procedure) within the Pharmacopoeial harmonisation process. The coordinating pharmacopoeia is the USP. The original text submitted to the PDG is published in the Pharmacopoeial harmonisation section.
本草案對應(yīng)于藥典協(xié)調(diào)過程中根據(jù)藥典討論小組（PDG）工作程序的第4 次修訂，第2 階段。協(xié)調(diào)藥典是美國藥典。提交給PDG 的原始文本發(fā)表在藥典協(xié)調(diào)部分。
Compared to the monograph published in the 11th Edition of the Ph. Eur., the following changes are proposed:
與歐洲藥典第11 版中公布的專論相比，提出以下更改：
Identification: limits for the diameters of both angular polyhedral granules and rounded/spheroidal granules revised to a maximum of about 35 μm based on the distribution of granule diameters and shapes found by testing maize starch from multiple manufacturers.
鑒別：根據(jù)對多家制造商的玉米淀粉測試發(fā)現(xiàn)的顆粒直徑和形狀分布，將角形多面體顆粒和圓形/ 球形顆粒的直徑限度修訂為最大約35μm。
Methylcellulose (0345)
甲基纖維素（0345）
Assay: calculation updated to align with the PDG sign - off text.
含量測定：計(jì)算更新以與PDG 批準(zhǔn)文本一致。
Nicotine ditartrate dihydrate (2599)
二水合酒石酸煙堿（2599）
Specific optical rotation: concentration of the solution and range updated; value calculated on the anhydrous substance.
比旋度：溶液濃度和范圍更新；數(shù)值基于無水物質(zhì)計(jì)算。
Related substances: water for chromatography R used for the preparation of the mobile phase; in the preparation of the test solution, mass expressed using more significant figures; in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution.
有關(guān)物質(zhì)：用于制備流動(dòng)相的色譜用水R；在制備供試溶液時(shí)，質(zhì)量用更多有效數(shù)字表示；在制備對照溶液（a）時(shí)，由于該溶液的定性用途，體積用較少有效數(shù)字表示。
Nitrendipine (1246)
尼群地平（1246）
Related substances: the quantitative style has been introduced; the limit of impurity C was updated; impurity A is now specified at 0.10%. These changes reflect the quality of the substances in approved medicinal products on the European market.
有關(guān)物質(zhì)：引入了定量方式；雜質(zhì)C 的限度更新；雜質(zhì)A 現(xiàn)在規(guī)定為0.10%。這些更改反映了歐洲市場上已批準(zhǔn)藥品中物質(zhì)的質(zhì)量。
Oxy tetracycline hydrochloride (0198)
鹽酸土霉素（0198）
Related substances: dilute hydrochloric acid R1 has been replaced by the stronger dilute hydrochloric acid R in order to reduce the volume of reagent required to perform the pH adjustment of the oxalic acid solution used in the solvent mixture.
有關(guān)物質(zhì)：稀鹽酸R1 已被更強(qiáng)的稀鹽酸R 取代，以減少對溶劑混合物中所用草酸溶液進(jìn)行pH 調(diào)節(jié)所需的試劑量。
Pentobarbital sodium (0419)
戊巴比妥鈉（0419）
First identification: tests relabelled due to addition of the second identification sub - section.
第一鑒別：由于添加了第二鑒別子部分，對試驗(yàn)重新進(jìn)行了標(biāo)記。
Second identification: sub - section added since the substance is used in pharmacies.
第二鑒別：由于該物質(zhì)在藥房使用，添加了子部分。
Peritoneal dialysis, solutions for (0862)
腹膜透析溶液（0862）
The monograph has been revised to reflect current practices and to align with the other dialysis monographs (0128, 0861 and 2770):
該專論已被修訂，以反映當(dāng)前實(shí)踐并與其他透析專論（0128、0861 和2770）保持一致：
-Tests section: Hydroxymethylfurfural: addition of clarification that the test is carried out only when the glucose - containing solution is heat - sterilised.-試驗(yàn)部分：
羥甲基糠醛：補(bǔ)充說明僅當(dāng)含葡萄糖溶液進(jìn)行熱滅菌時(shí)才進(jìn)行該試驗(yàn)。
-Labelling section: addition of the requirement that the peritoneal dialysis solution is sterile.
-標(biāo)簽部分：添加了腹膜透析溶液必須無菌的要求。
Pivmecillinam hydrochloride (1359)
鹽酸匹美西林（1359）
Related substances: the preparation of reference solution (c) has been amended to take account the new lyophilised form of pivmecillinam impurity C CRS.
有關(guān)物質(zhì)：對照溶液（c）的制備已作修改，以考慮匹美西林雜質(zhì)C CRS 的新凍干形式。
Propylene glycol dilaurate (2087)
丙二醇二月桂酸酯（2087）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.
含量測定：柱直徑從7 毫米改為7.5 毫米。直徑為7 毫米的柱子不再生產(chǎn)。
Propylene glycol monocaprylate (2799)
丙二醇單辛酸酯（2799）
Assay: column diameter changed from 7.0 mm to 7.5 mm. Columns with a diameter of 7.0 mm are no longer manufactured.
含量測定：柱直徑從7.0 毫米改為7.5 毫米。直徑為7.0 毫米的柱子不再生產(chǎn)。
Propylene glycol monolaurate (1915)
丙二醇單月桂酸酯（1915）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.
含量測定：柱直徑從7 毫米改為7.5 毫米。直徑為7 毫米的柱子不再生產(chǎn)。
Remifentanil hydrochloride (2644)
鹽酸瑞芬太尼（2644）
Characters: in view of feedback from users, the reference to solubility in acetonitrile has been deleted.
性狀：鑒于用戶反饋，關(guān)于在乙腈中溶解度的表述已被刪除。
Identification by IR: the use of a reference spectrum has been added as an alternative to the reference standard.
紅外鑒別：已添加使用參考光譜作為參考標(biāo)準(zhǔn)的替代方法。
Methyl acrylate: water for chromatography R has been replaced by an apolar solvent for the preparation of the test solution to avoid in - situ formation of methyl acrylate; the method parameters have been adjusted accordingly.
丙烯酸甲酯：在制備測試溶液時(shí)，色譜用水R 已被非極性溶劑取代，以避免現(xiàn)場形成丙烯酸甲酯；方法參數(shù)已相應(yīng)調(diào)整。
Rifamycin sodium (0432)
利福霉素鈉（0432）
Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024;12 - 26).
生產(chǎn)：根據(jù)從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)以及這些試驗(yàn)的殘留部分的策略，該部分已被刪除（見布拉托斯M、科拉伊- 羅賓O、安東尼M、沙頓E?！稓W洲藥典》用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)檢測：一個(gè)時(shí)代的終結(jié)。從《歐洲藥典》中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及其殘留的策略。歐洲制藥生物科學(xué)筆記。2024;12 - 26）。
Rivaroxaban (2932)
利伐沙班（2932）
Enantiomeric purity: in the preparation of the test solution, mass and volume expressed using more significant figures for better accuracy; calculation method moved up; system suitability test introduced to the signal - to - noise ratio to verify the sensitivity of the procedure.
對映體純度：在制備供試液時(shí)，為了更高的準(zhǔn)確性，使用更多有效數(shù)字表示質(zhì)量和體積；計(jì)算方法提前；引入系統(tǒng)適用性試驗(yàn)以信噪比來驗(yàn)證該程序的靈敏度。
Ropivacaine hydrochloride monohydrate (2335)
鹽酸羅哌卡因一水合物（2335）
Enantiomeric purity: calculation method updated to reflect the manufacturer's approach; grade of water used amended in accordance with the Technical Guide; in the preparation of the test solution, mass and volume expressed using more significant figures for better accuracy; in the preparation of reference solution (b), masses expressed using fewer significant figures due to qualitative use of this solution; migration time of ropivacaine and relative migration of impurity G included.
對映體純度：計(jì)算方法更新以反映制造商的方法；所用的水的級別根據(jù)技術(shù)指南進(jìn)行了修訂；在制備供試液時(shí)，為了更高的準(zhǔn)確性，使用更多有效數(shù)字表示質(zhì)量和體積；在制備對照溶液（b）時(shí)，由于該溶液的定性使用，使用較少的有效數(shù)字表示質(zhì)量；包括羅哌卡因的遷移時(shí)間和雜質(zhì)G 的相對遷移。
Related substances: grades of solvents amended in accordance with the Technical Guide; in the preparation of the test solution, mass and volume expressed using more significant figures for better accuracy.
有關(guān)物質(zhì)：溶劑的級別根據(jù)技術(shù)指南進(jìn)行了修訂；在制備供試液時(shí)，為了更高的準(zhǔn)確性，使用更多有效數(shù)字表示質(zhì)量和體積。
Rotigotine (3014)
羅替戈?。?014）
Enantiomeric purity: calculation method moved up; additional system suitability test (signal - to - noise ratio) introduced to verify the sensitivity of the procedure; in the preparation of test solution, mass and volume expressed using more significant figures for better accuracy.
對映體純度：計(jì)算方法提前；引入額外的系統(tǒng)適用性試驗(yàn)（信噪比）以驗(yàn)證該程序的靈敏度；在制備供試液時(shí)，為了更高的準(zhǔn)確性，使用更多有效數(shù)字表示質(zhì)量和體積。
Related substances: in the preparation of reference solution (b), volumes expressed using fewer significant figures due to the qualitative use of this solution.
有關(guān)物質(zhì)：在制備對照溶液（b）時(shí)，由于該溶液的定性使用，使用較少的有效數(shù)字表示體積。
Salicylic acid (0366)
水楊酸（0366）
Solution S: preparation transferred in the only test in which it is used, the test for chlorides.
溶液S：制備轉(zhuǎn)移至其唯一使用的試驗(yàn)中，即氯化物試驗(yàn)。
Related substances: column length decreased reflecting the dimensions of the particular column used in the validation of the proposed optimised procedure; grade of water used in the mobile phase amended in accordance with the Technical Guide (2022); quantitation of impurities optimised, carried out versus a 0.05 per cent impurity B solution; injection volume decreased 5 fold and concentration of the test solution increased 10 fold to achieve sufficient sensitivity; first system suitability test acceptance criterion based on a minimum signal - to - noise ratio of a 0.05 - per cent diluted test solution to ensure the detection of unknown impurities structurally close to the API, since the detector response of the API is lower than the detector response for impurity B which was used to quantitate all impurities; second system suitability test acceptance criterion widened based on recent experimental results injecting the proposed corresponding reference solution; limits expressed in the quantitative style.
有關(guān)物質(zhì)：柱長縮短以反映在驗(yàn)證所提議的優(yōu)化程序中使用的特定色譜柱的尺寸；流動(dòng)相中使用的水的級別根據(jù)技術(shù)指南（2022 年）進(jìn)行了修訂；雜質(zhì)的定量進(jìn)行了優(yōu)化，相對于0.05% 的雜質(zhì)B 溶液進(jìn)行；進(jìn)樣體積減少5 倍，供試液濃度增加10 倍以達(dá)到足夠的靈敏度；第一個(gè)系統(tǒng)適用性試驗(yàn)的接受標(biāo)準(zhǔn)基于0.05% 稀釋供試液的最低信噪比，以確保檢測到與原料藥結(jié)構(gòu)相近的未知雜質(zhì)，因?yàn)樵纤幍臋z測器響應(yīng)低于用于定量所有雜質(zhì)的雜質(zhì)B 的檢測器響應(yīng)；根據(jù)最近注射所提議的相應(yīng)對照溶液的實(shí)驗(yàn)結(jié)果，第二個(gè)系統(tǒng)適用性試驗(yàn)的接受標(biāo)準(zhǔn)放寬；限度以定量方式表示。
Assay: colorimetric end - point detection replaced by more accurate and precise potentiometric end - point detection.
含量測定：比色終點(diǎn)檢測被更準(zhǔn)確和精確的電位終點(diǎn)檢測所取代。
Impurities: section updated in accordance with the limits in the test for related substances.
雜質(zhì)：該部分已根據(jù)有關(guān)物質(zhì)測試中的限度進(jìn)行了更新。
Sitagliptin phosphate monohydrate (2778)
磷酸西格列汀一水合物（2778）
Identification C: sample size and volume of solvent expressed using fewer significant figures due to qualitative use of this test.
鑒別C：由于該測試為定性用途，樣品量和溶劑量使用較少的有效數(shù)字表示。
Enantiomeric purity: in the preparation of the test solution, sample size expressed with one more significant figure due to its use in the preparation of reference solution (a), which is used for a quantitative test; signal - to - noise ratio; calculation method updated to reflect the manufacturer's approach (reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.
對映體純度：在制備供試液時(shí)，由于其用于制備用于定量測試的對照溶液（a），樣品量以多一位有效數(shù)字表示；信噪比；計(jì)算方法已更新，以反映制造商的方法（報(bào)告閾值由額外的系統(tǒng)適用性測試（最低信噪比）取代，以驗(yàn)證該程序的靈敏度）。
Sodium hydrogen carbonate (0195)
碳酸氫鈉（0195）
Ammonium: based on new data, preparation of solutions amended to bring to a strongly alkaline pH.
銨：根據(jù)新數(shù)據(jù)，溶液的制備進(jìn)行了修訂，使其pH 值呈強(qiáng)堿性。
Sodium polystyrene sulfonate (1909)
聚苯乙烯磺酸鈉（1909）
Definition: amended to clarify that the monograph covers a sodium sulfonated copolymer of styrene and divinylbenzene, which has very different properties from the sodium sulfonated polystyrene homopolymer; structure added.
定義：進(jìn)行了修訂，以明確該專論涵蓋苯乙烯和二乙烯基苯的磺化鈉共聚物，其性質(zhì)與磺化聚苯乙烯均聚物有很大不同；添加了結(jié)構(gòu)。
Styrene: more accurate quantities mentioned; run time, retention time and chromatogram added; grade of solvent for mobile phase and reagent used to describe the stationary phase amended.
苯乙烯：提及了更準(zhǔn)確的數(shù)量；添加了運(yùn)行時(shí)間、保留時(shí)間和色譜圖；對流動(dòng)相溶劑的級別和用于描述固定相的試劑進(jìn)行了修訂。
Starch, hydroxypropyl (2165)
羥丙基淀粉（2165）
Identification A: Maize - based hydroxypropyl starch criteria revised in - line with the revision to the Maize starch (0344) monograph.
鑒別A：基于玉米的羥丙基淀粉標(biāo)準(zhǔn)已根據(jù)玉米淀粉（0344）專論的修訂進(jìn)行了修訂。
Starches, hydroxyethyl (1785)
羥乙基淀粉（1785）
Molecular weight (Mw) and molecular weight distribution: system suitability criteria widened in order to better reflect the variability in the method reported by several laboratories; unit specified (daltons); test name revised to 'Molecular weight (Mw) and molecular mass distribution' to accurately describe the value measured by the test (English text only).
分子量（Mw）和分子量分布：系統(tǒng)適用性標(biāo)準(zhǔn)擴(kuò)大，以便更好地反映幾個(gè)實(shí)驗(yàn)室報(bào)告的方法中的變異性；指定了單位（道爾頓）；測試名稱修訂為 “分子量（Mw）和分子質(zhì)量分布”，以準(zhǔn)確描述測試測量的值（僅英文文本）。
Editorial changes have also been made throughout the monograph to align with the current style guide.
整個(gè)專論也進(jìn)行了編輯修改，以符合當(dāng)前的風(fēng)格指南。
Streptomycin sulfate (0053)
硫酸鏈霉素（0053）
Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos S, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeu Bio Sci Notes. 2024 - 12 - 26).
生產(chǎn)：根據(jù)從《歐洲藥典》中刪除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)以及這些試驗(yàn)殘余的策略，該部分已被刪除（見Bratos S、Kolaj - Robin O、Antoni M、Charton E.《歐洲藥典》使用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)測試：一個(gè)時(shí)代的結(jié)束。從《歐洲藥典》中刪除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及其殘余的策略。Pharmeu Bio Sci Notes. 2024 - 12 - 26）。
Editorial changes have also been made throughout the monograph.
整個(gè)專論也進(jìn)行了編輯修改。
Sucrose monopalmitate (2319)
單棕櫚酸蔗糖酯（2319）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.
測定：柱直徑從7 毫米變?yōu)?.5 毫米。直徑為7 毫米的柱子不再生產(chǎn)。
Sucrose stearate (2318)
硬脂酸蔗糖酯（2318）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.
測定：柱直徑從7 毫米變?yōu)?.5 毫米。直徑為7 毫米的柱子不再生產(chǎn)。
Tapentadol hydrochloride (3035)
鹽酸氫可酮（3035）
Identification by IR. reference spectrum added as an alternative to chemical reference substance.
通過紅外光譜鑒別。添加參考光譜作為化學(xué)對照品的替代物。
Enantiomeric purity: calculation method moved up; reporting threshold replaced by an additional system suitability test (minimum signal-to -noise ratio) to verify the sensitivity of the procedure.
對映體純度：計(jì)算方法上移；報(bào)告閾值被額外的系統(tǒng)適用性測試（最小信噪比）取代，以驗(yàn)證該程序的靈敏度。
Tobramycin (0645)
妥布霉素（0645）
Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12 - 26).
生產(chǎn)：根據(jù)從歐洲藥典中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)以及這些試驗(yàn)的剩余部分的策略，該部分已被刪除（見Bratos M、Kolaj - Robin O、Antoni M、Charton E。歐洲藥典用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)測試：一個(gè)時(shí)代的結(jié)束。從歐洲藥典中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及其痕跡的策略。Pharmeur 生物科學(xué)筆記。2024：12 - 26）。
Trypsin (0694)胰蛋白酶（0694）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12 - 26).
生產(chǎn)：根據(jù)從歐洲藥典中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)以及這些試驗(yàn)的剩余部分的策略，該部分的一部分已被刪除（見Bratos M、Kolaj - Robin O、Antoni M、Charton E。歐洲藥典用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)測試：一個(gè)時(shí)代的結(jié)束。從歐洲藥典中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及其痕跡的策略。Pharmeur 生物科學(xué)筆記。2024：12 - 26）。
Editorial changes have also been made throughout the monograph (French version only).
整個(gè)專論也進(jìn)行了編輯更改（僅法語版本）。
Urofollitropin (0958)
尿促卵泡素（0958）
Assay: the procedure has been modified to remove the mercury - containing compound thiomersal (REACH) as an example of a suitable antimicrobial preservative.
測定：該程序已被修改，以去除含汞化合物硫柳汞（REACH）作為合適的抗菌防腐劑的一個(gè)例子。
Urokinase (0695)
尿激酶（0695）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12 - 26).
生產(chǎn)：根據(jù)從歐洲藥典中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)以及這些試驗(yàn)的剩余部分的策略，該部分的一部分已被刪除（見Bratos M、Kolaj - Robin O、Antoni M、Charton E。歐洲藥典用豚鼠和貓進(jìn)行組胺和降壓物質(zhì)測試：一個(gè)時(shí)代的結(jié)束。從歐洲藥典中去除組胺和降壓物質(zhì)的動(dòng)物試驗(yàn)及其痕跡的策略。Pharmeur 生物科學(xué)筆記。2024：12 - 26）。
Editorial changes have also been made throughout the monograph.
整個(gè)專論也進(jìn)行了編輯更改。
Ursodeoxycholic acid (1275)
熊去氧膽酸（1275）
Identification: TLC method description included under identification B (second identification) since the previously cross - referenced procedure for impurity C by TLC has been replaced by a new LC procedure.
鑒別：鑒別項(xiàng)下包含TLC 法描述B（第二種鑒別方法），因?yàn)橹巴ㄟ^TLC 對雜質(zhì)C 的交叉引用程序已被新的液相色譜（LC）程序取代。
Impurity C: TLC changed to LC procedure covering the control of additional impurity J.
雜質(zhì)C：將薄層色譜法（TLC）改為液相色譜法（LC）程序，以涵蓋對額外雜質(zhì)J 的控制。
Related substances: in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution; reagent used to describe stationary LC phase modified; tolerance for the column temperature changed from ±1 °C to ±2 °C; quantitative style now prescribed.
有關(guān)物質(zhì)：在制備對照溶液（a）時(shí)，由于該溶液用于定性，體積表示使用較少的有效數(shù)字；用于描述液相色譜固定相的試劑已修改；柱溫容差從 ±1°C 變?yōu)?±2°C；現(xiàn)在規(guī)定了定量方式。
Impurities: impurity J introduced.
雜質(zhì)：引入了雜質(zhì)J。
Zanamivir hydrate (2611)
扎那米韋水合物（2611）
Loss on drying: the test by loss on drying was reported to be inadequate to release all the water due to the crystalline structure of zanamivir; change to a micro determination method (evaporation technique) to allow a more accurate determination of the water content.
干燥失重：據(jù)報(bào)道，由于扎那米韋的晶體結(jié)構(gòu)，干燥失重試驗(yàn)不足以釋放所有水分；改為微量測定法（蒸發(fā)技術(shù)），以便更準(zhǔn)確地測定水分含量。
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