近日，EDQM官网刊登了关于新版欧洲药典通论2.2.46《色谱分离技术》修订的公告，新的通论2.2.46《色谱分离技术》现已在《欧洲药典》第11版（Ph. Eur. 11.0，）中提供，并将于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).

《欧洲药典》已对通论第2.2.46章《色谱分离技术》进行修订，该章节由药典讨论小组（PDG）于2021年9月28日签署。修订后的章节现已在《欧洲药典》第11版（Ph. Eur. 11.0，实施日期：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.

该章节适用于色谱分析程序，并补充了关于薄层色谱（2.2.7）、气相色谱（2.2.28）、液相色谱（2.2.29）和尺寸排阻色谱（2.2.30）的通论。除了色谱特征的定义外，它还包含LC和GC程序的系统适用性要求，补充了各个各论中给出的要求。

The main changes made for harmonisation purposes are:

主要修改内容：

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;

信噪比基于半高时峰宽的20倍的基础，但如果无法获得，则允许半高处至少5倍峰宽的基础;

 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;

默认对称因子范围已从0.8-1.5扩展到0.8-1.8；它适用于检查和含量测定;

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

保留时间和相对保留不再在文中作出要求，而在各个专论中作为资料性信息; 

 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;

含量测定中的系统重复性要求现已适用于活性成分和辅料，纯的成分的目标值为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;

关于色谱条件的调整，需要强调的是，这种调整只是在药典程序的基础上进行的。还明确指出，始终需要符合系统适用性测试（但不再是允许色谱条件调整的唯一因素），在对药典程序进行调整时可能需要额外的确认测试，并且多方面的调整会触发风险评估的需要；

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;

对于具有等度洗脱的液相色谱，固定相调整的协调条件比前一版更严格；柱尺寸的调整现在基于L / dp比，就像美国药典（USP）<第621章>中已经出现的情况一样，但要求更严格；还描述了调整流动相组成、流量和进样量的协调条件；

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

已就LC中的梯度洗脱达成了与等度洗脱类似的要求和公差；

 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;

在气相色谱中，调节色谱柱尺寸，进样体积，分离比，进样口和传输线温度的条件（后两者对于Ph. Eur.来说是新要求）已经协调;

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

超临界流体色谱的调整已被删除，因为该技术未在任何Ph. Eur.专论中使用。

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).

与原版通则2.2.46的情况一样，系统灵敏度应根据最低信噪比进行检查。此默认要求仅适用于包含报告阈值（或旧专著中的忽略限值）的各论的LC和GC测试（而不是测定）。

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.

当地要求，即特定于单个药典的要求，将被放置在白色（◊◊）之间。对于Ph. Eur.章节，这些要求包括延迟因子的同义词和确定信噪比的指导（例如要使用的溶液）。最后，术语“相对保留时间”或“RRT”将不会在Ph. Eur中使用。

关于色谱条件的调整：

药典上各品种项下的色谱条件，可以进行适当的调整，并满足系统适用性的要求。目前，EP/USP/JP均对于色谱条件的调整作出了更细致和明确的要求，而当前中国药典2020版，还没有这样的详细描述。

中国药典2020年版高效液相色谱法项下对调整的描述：

中国药典2020年版气相色谱法项下对调整的描述：