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近日，EDQM官網(wǎng)刊登了關(guān)于新版歐洲藥典通論2.2.46《色譜分離技術(shù)》修訂的公告，新的通論2.2.46《色譜分離技術(shù)》現(xiàn)已在《歐洲藥典》第11版（Ph. Eur. 11.0，）中提供，并將于2023年1月1日生效！

General chapter2.2.46. Chromatographic separation techniques has been revised to incorporate the provisions of the pharmacopoeial harmonisation text, signed-off by the Pharmacopoeial Discussion Group (PDG) on 28 September 2021. The revised chapter is now available in the 11th Edition of the Europe Pharmacopoeia (Ph. Eur. 11.0, implementation date: 1 January 2023).

《歐洲藥典》已對(duì)通論第2.2.46章《色譜分離技術(shù)》進(jìn)行修訂，該章節(jié)由藥典討論小組（PDG）于2021年9月28日簽署。修訂后的章節(jié)現(xiàn)已在《歐洲藥典》第11版（Ph. Eur. 11.0，實(shí)施日期：2023年1月1日）中提供。

This general chapter applies to chromatographic analytical procedures and supplements the general chapters onThin-layer chromatography (2.2.7), Gas chromatography (2.2.28), Liquid chromatography (2.2.29) and Size-exclusion chromatography (2.2.30). In addition to definitions of chromatographic features, it contains system suitability requirements for LC and GC procedures, complementing those given in the individual monographs.

該章節(jié)適用于色譜分析程序，并補(bǔ)充了關(guān)于薄層色譜（2.2.7）、氣相色譜（2.2.28）、液相色譜（2.2.29）和尺寸排阻色譜（2.2.30）的通論。除了色譜特征的定義外，它還包含LC和GC程序的系統(tǒng)適用性要求，補(bǔ)充了各個(gè)各論中給出的要求。

The main changes made for harmonisation purposes are:

主要修改內(nèi)容：

the signal-to-noise ratio is     based on a baseline of 20 times the peak width at half height but if this     is not obtainable, a baseline of at least 5 times the width at half-height     is permitted;

信噪比基于半高時(shí)峰寬的20倍的基礎(chǔ)，但如果無(wú)法獲得，則允許半高處至少5倍峰寬的基礎(chǔ);

 the default symmetry factor range     has been extended from 0.8-1.5 to 0.8-1.8; it applies to both tests and     assays;

默認(rèn)對(duì)稱因子范圍已從0.8-1.5擴(kuò)展到0.8-1.8；它適用于檢查和含量測(cè)定;

 the text now states that retention     times and relative retentions are not requirements but are given     for information in the monographs;

保留時(shí)間和相對(duì)保留不再在文中作出要求，而在各個(gè)專論中作為資料性信息; 

 the system repeatability requirement     in the assay now applies to both active substances and excipients, with a target value of 100 per cent for a     pure substance;

含量測(cè)定中的系統(tǒng)重復(fù)性要求現(xiàn)已適用于活性成分和輔料，純的成分的目標(biāo)值為100%;

 with regard to adjustments of     chromatographic conditions, it is stressed that such adjustments are     made only on the basis of the pharmacopoeial procedure. The fact that     compliance with the system suitability test is always required (but is no     longer the only factor prompting adjustments), that additional     verification tests may be required when adjustments are made to a     pharmacopoeial procedure and that multiple adjustments would trigger the     need for a risk assessment is also clearly stated;

關(guān)于色譜條件的調(diào)整，需要強(qiáng)調(diào)的是，這種調(diào)整只是在藥典程序的基礎(chǔ)上進(jìn)行的。還明確指出，始終需要符合系統(tǒng)適用性測(cè)試（但不再是允許色譜條件調(diào)整的唯一因素），在對(duì)藥典程序進(jìn)行調(diào)整時(shí)可能需要額外的確認(rèn)測(cè)試，并且多方面的調(diào)整會(huì)觸發(fā)風(fēng)險(xiǎn)評(píng)估的需要；

for liquid chromatography with isocratic     elution, the harmonised conditions for adjustment of the stationary     phase are stricter than in the former chapter; adjustments of column     dimensions are now based on the L/dp ratio, as was     already the case in United States Pharmacopeia (USP) chapter <621>,     but with stricter requirements; harmonised conditions are also described     for the adjustment of mobile phase composition, flow rate and injection     volume;

對(duì)于具有等度洗脫的液相色譜，固定相調(diào)整的協(xié)調(diào)條件比前一版更嚴(yán)格；柱尺寸的調(diào)整現(xiàn)在基于L / dp比，就像美國(guó)藥典（USP）<第621章>中已經(jīng)出現(xiàn)的情況一樣，但要求更嚴(yán)格；還描述了調(diào)整流動(dòng)相組成、流量和進(jìn)樣量的協(xié)調(diào)條件；

similar requirements and tolerances as for isocratic     elution have been agreed for gradient elution in     LC;

已就LC中的梯度洗脫達(dá)成了與等度洗脫類似的要求和公差；

 in gas chromatography, the     conditions for adjustment of the column dimensions, injection volume,     split ratio, injection port and transfer-line temperatures (the latter two     being new for Ph. Eur.) have been harmonised;

在氣相色譜中，調(diào)節(jié)色譜柱尺寸，進(jìn)樣體積，分離比，進(jìn)樣口和傳輸線溫度的條件（后兩者對(duì)于Ph. Eur.來(lái)說(shuō)是新要求）已經(jīng)協(xié)調(diào);

 the adjustments for supercritical     fluid chromatography have been deleted as this     technique is not used in any Ph. Eur. monographs.

超臨界流體色譜的調(diào)整已被刪除，因?yàn)樵摷夹g(shù)未在任何Ph. Eur.專論中使用。

As was the case in the former version of general chapter2.2.46, system sensitivity is to be checked on the basis of a minimum signal-to-noise ratio. This default requirement only applies to LC and GC tests (and not assays) for monographs that include a reporting threshold (or a disregard limit, in older monographs).

與原版通則2.2.46的情況一樣，系統(tǒng)靈敏度應(yīng)根據(jù)最低信噪比進(jìn)行檢查。此默認(rèn)要求僅適用于包含報(bào)告閾值（或舊專著中的忽略限值）的各論的LC和GC測(cè)試（而不是測(cè)定）。

Local requirements, i.e. specific to an individual pharmacopoeia, will be placed between white diamonds (◊◊). For the Ph. Eur. chapter, these requirements include synonyms for retardation factors and guidance for determining the signal-to-noise ratio (e.g. solution to be used). Lastly, the term “relative retention time” or “RRT” will not be used in the Ph. Eur.

當(dāng)?shù)匾?，即特定于單個(gè)藥典的要求，將被放置在白色（◊◊）之間。對(duì)于Ph. Eur.章節(jié)，這些要求包括延遲因子的同義詞和確定信噪比的指導(dǎo)（例如要使用的溶液）。最后，術(shù)語(yǔ)“相對(duì)保留時(shí)間”或“RRT”將不會(huì)在Ph. Eur中使用。

關(guān)于色譜條件的調(diào)整：

藥典上各品種項(xiàng)下的色譜條件，可以進(jìn)行適當(dāng)?shù)恼{(diào)整，并滿足系統(tǒng)適用性的要求。目前，EP/USP/JP均對(duì)于色譜條件的調(diào)整作出了更細(xì)致和明確的要求，而當(dāng)前中國(guó)藥典2020版，還沒(méi)有這樣的詳細(xì)描述。

中國(guó)藥典2020年版高效液相色譜法項(xiàng)下對(duì)調(diào)整的描述：

中國(guó)藥典2020年版氣相色譜法項(xiàng)下對(duì)調(diào)整的描述：