中文字幕一级黄色A级片|免费特级毛片。性欧美日本|偷拍亚洲欧美1级片|成人黄色中文小说网|A级片视频在线观看|老司机网址在线观看|免费一级无码激情黄所|欧美三级片区精品网站999|日韩av超碰日本青青草成人|一区二区亚洲AV婷婷

近日，ECA發(fā)布了《歐洲藥典》系統(tǒng)適用性試驗Q&A，其中整理了其“系統(tǒng)適用性試驗（SST）與高效液相色譜（HPLC）方法故障排除”培訓(xùn)中的問答，包括系統(tǒng)適用性可接受標(biāo)準(zhǔn)、系統(tǒng)重復(fù)性、系統(tǒng)精密度、保留時間偏差等，如下：

1.1 In Ph. Eur. 2.2.46, acceptable system suitability criteria have recently been introduced (e.g. tailing factor). In our laboratory, there is a validated assay method for the finished product in which the tailing factor is not evaluated. Should we start evaluating the Ph. Eur. criteria in addition to the criteria of the established method?

《歐洲藥典》2.2.46章近期新增了系統(tǒng)適用性的可接受標(biāo)準(zhǔn)（如拖尾因子）。我們實驗室有一個已驗證的成品含量檢測方法，該方法中未評估拖尾因子。除已建立方法的標(biāo)準(zhǔn)外，我們是否應(yīng)開始評估《歐洲藥典》規(guī)定的這些標(biāo)準(zhǔn)？

The chapter 2.2.46 describes all relevant SST parameters which can be defined. However, it is recommended to prepare a rationale e.g. for the definition of the respective analytical target profile (ATP) which SST parameters are really relevant for the respective analytical procedure. E.g., if there is no criticality with respect to the separation quality, it is possible not to test the tailing factor, but to apply other SST parameters like chromatographic resolution.

《歐洲藥典》2.2.46章列出了所有可定義的相關(guān)系統(tǒng)適用性試驗（SST）參數(shù)。但建議制定相關(guān)依據(jù)（例如針對相應(yīng)分析目標(biāo)譜圖（ATP）的定義），明確哪些SST參數(shù)與特定分析流程真正相關(guān)。例如，若分離質(zhì)量不存在關(guān)鍵影響，可不檢測拖尾因子，而是采用色譜分離度等其他SST參數(shù)。

The European Pharmacopoeia Style Guide recommends to use one or more SST parameters as general information.

《歐洲藥典格式指南》建議采用一項或多項SST參數(shù)作為通用信息。

1.2 Are the system suitability criteria for ion chromatography the same as those for liquid chromatography?

離子色譜法與液相色譜法的系統(tǒng)適用性標(biāo)準(zhǔn)是否相同？

Yes, the principles are identical.

相同，二者原理一致。

1.3 Is system repeatability for residual solvents by gas chromatography evaluated?

采用氣相色譜法測定殘留溶劑時，是否需要評估系統(tǒng)重復(fù)性？

System repeatability is generally described in chapter 2.2.46 and can also be applied for gas chromatography. One possibility is to evaluate the system repeatability at the "threshold of toxicological concern". However, it might be also appropriate to define the SST (e.g. for Headspace GC) by using S/N ratio, chromatographic resolution and peak shape (tailing factor).

系統(tǒng)重復(fù)性在2.2.46章中有通用說明，該要求同樣適用于氣相色譜法。一種做法是在“毒理學(xué)關(guān)注閾值”水平條件下評估系統(tǒng)重復(fù)性。此外，也可通過信噪比（S/N）、色譜分離度和峰形（拖尾因子）來定義系統(tǒng)適用性試驗（SST）的標(biāo)準(zhǔn)（如針對頂空氣相色譜法）。

In case of the "New European Pharmacopoeia Style Guide", chapter 2.2.46 is also referenced in the description for the SST describing gas chromatography.

在新的《歐洲藥典格式指南》中，氣相色譜法相關(guān)的系統(tǒng)適用性試驗（SST）說明部分也引用了2.2.46章的內(nèi)容。

1.4 Is it mandatory to evaluate system precision for organic impurities/related substances determined by liquid chromatography, given that there is no relevant reference in the Ph. Eur. (only in the USP)?

采用液相色譜法測定有機(jī)雜質(zhì)/相關(guān)物質(zhì)時，系統(tǒng)精密度評估是否為強(qiáng)制性要求？《歐洲藥典》中無相關(guān)提及（僅USP有規(guī)定）。

In Ph. Eur. system precision is described in a general way. Although it might not be mandatory (acc. Ph. Eur.), system precision is a good SST parameter, especially near the quantitation limit in order to check the variability of the analytical procedure.

《歐洲藥典》對系統(tǒng)精密度有通用描述。盡管根據(jù)《歐洲藥典》規(guī)定，系統(tǒng)精密度評估可能并非強(qiáng)制性要求，但它仍是一項優(yōu)良的SST參數(shù)，尤其在接近定量限的情況下，可用于檢驗分析流程的變異性。

1.5 During the training it was mentioned that, for example, a retention time of 2.0 min ± 0.2 min can be defined, corresponding to a 10% variation in retention time. Would it therefore be acceptable to perform an HPLC identification test with a maximum 10% difference in retention time between the sample and the working standard? If yes, which guideline is applicable?

培訓(xùn)中提到，例如可將保留時間定義為2.0分鐘±0.2分鐘，對應(yīng)10%的保留時間變異。那么，在高效液相色譜（HPLC）鑒別試驗中，樣品與工作標(biāo)準(zhǔn)品的保留時間差異最大為10%，這種情況是否可接受？若可接受，應(yīng)遵循哪項指南？

There is no guideline in place which describes the variability of the retention time, e.g. for identification tests. The example is an approach and the variability should be justified in a rationale (or even ATP).

目前尚無針對鑒別試驗等場景中保留時間變異性的專項指南。培訓(xùn)中提及的案例僅為一種參考方法，保留時間的變異性需在依據(jù)文件（甚至分析目標(biāo)譜圖（ATP））中進(jìn)行合理性說明。