EP修订液体色度通则 20200212

European Pharmacopoeia revises general chapter on degree of coloration of liquids

EP修订液体色度通则

European Pharmacopoeia

General text/chapter

News

12 February 2020

Strasbourg, France

At its 165th session in November 2019, the European Pharmacopoeia Commissionadopted a new version of one of its widely used general methods, chapter 2.2.2. Degree of coloration of liquids, which has been extensively revised to include the instrumental method. The revised chapter will be published in European Pharmacopoeia (Ph. Eur.) Supplement 10.3, available in July 2020 (implementation date: 1 January 2021).

在2019年11月的第165次会议中，EP委员会采纳了广泛使用的通则2.2.2液体色度的新版，该通则进行了大量修订，在其中包括了仪器方法。修订后的内容将发布在EP10.3增补中，2020年7月可获得（实施日期为2021年1月1日）。

This chapter now describes three methods:

该章节现在阐述有3种方法：

• in method I (visual method), the colours are compared in diffused daylight, viewing horizontally against a white background;

• 方法I（目视法），自然光下置白色背景上，从上至下垂直观察比较

• in method II (visual method), the colours are compared in diffused daylight, viewing vertically against a white background;

• 方法II（目视法），自然光下置白色背景前，从前至后平视观察比较

• method III is the instrumental method – this part of the text has been harmonised with the USP and the JP in the Pharmacopoeial Discussion Group (PDG).

• 方法III为仪器方法—该部分内容已由药典讨论组（PDG）与USP和JP协调一致

Instrumental methods for measurement of colour provide more objective data than the subjective viewing of colours by a small number of individuals. With adequate maintenance and calibration, they can provide accurate, precise and consistent measurements of colour that do not drift over time. Through extensive colour-matching experiments involving human subjects with normal colour vision, distribution coefficients (weighting factors) have been established for each wavelength in the visible spectrum, giving the relative amount of stimulation of each receptor type caused by the light of that wavelength.

仪器方法测量色度可提供比少量人员通过目视更为客观的数据。经过充分的维护和校正，该方法可得出准确、精密和一致的色度测量结果，不会随时间漂移。通过对具备正常颜色视觉的人体对象进行的大量配色实验，已为可见光谱中每个波长建立了分配系数（权重因子），基于此为该波长的光引起的每种接收类型模拟出相对数量。

At present, however, the specifications indicatedin the Ph. Eur. are all based on visual determination and an exact correlation between visual and instrumental results is not always possible, depending onthe ability of the analyst to differentiate between colour grades (visual method) and on the equipment settings. Hence, when using chapter2.2.2, the analyst is asked to report the results together with the method used: method I, II or III.

当然，目前在EP中指定的标准是基于目测法，而实际上并无法完全将目测结果与仪器检测结果一一对应，其对应情况取决于化验员对不同色度（目视法）的区分和仪器的设置。因此，在应用通则2.2.2时，要求化验员报告结果时同时报告所用方法：方法I、II或III。

The instrumental method, when used instead of one of the visual methods currently prescribed in individual monographs, is nevertheless considered to be an alternative method and, as such, its use must meet the requirements of the Ph. Eur. General notices, which state: “the tests and assays described are the official methods upon which the standards of the Pharmacopoeia are based. With the agreement of the competent authority, alternative methods of analysis may be used for control purposes, provided that the methods used enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were used. In the event of doubt or dispute, the methods of analysis of the Pharmacopoeia are alone authoritative.”

如果使用仪器方法取代当前专论中所述的任一目视法，则会认为是使用替代方法，因此必须符合EP“凡例”中的要求“所述检测和方法为该EP标准下的官方方法。如果经药监当局同意，可使用替代分析方法用作控制，前提是所用方法能够给出与官方指定方法相同的是否符合标准的明确结论。如有疑问或争议，以药典指定检测方法为准”。

       文章来源：允咨GMP制药技术

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