歐洲藥典通用章節更新—紅外吸收分光光度法

05-16

來自專欄藥品註冊管理

NEWS

新聞

06 APRIL 2018

2018.04.06

STRASBOURG, FRANCE

法國，斯特拉斯堡

At its 160th

session (March 2018) the Ph. Eur. Commission adopted a new version of one of its

major general methods, which has undergone extensive revision. The chapter on

Infrared Absorption Spectrophotometry (2.2.24) is one of the original

cornerstones of pharmacopoeial testing, referenced in many general texts and

more than 1200 individual monographs.

在歐洲藥典委員會第160次大會上，採用了一種新的通過了廣泛修訂的通用方法。紅外吸收分光光度法(2.2.24)章節是藥典方法的基礎之一，在許多基礎文本和1200多個人專著中均有引用。

The chapter has

been completely rewritten and its structure updated to include:

該章節已經完成了修訂，其更新包括：

· the removal of monochromator instruments as they are now

obsolete;

· 由於單色儀過時，將其移除；

· an extended description of Fourier-transform

spectrometers (FT-IR) using attenuated total reflection (ATR) and related

criteria for the control of equipment performance;

· 使用衰減全反射(ATR)技術對傅里葉變換光譜儀(ft-IR)進行了進一步描述，並給出了設備性能控制的相關標準；

· a new "principle" section, with distinction

between near-, mid- and far-infrared;

· 新的「原則」部分，區分近紅外、中紅外和遠紅外；

· new sections on applications and limitations;

· 新設有關使用和限制章節；

· a reduction from 7 to 4 band positions for verification

of the wavenumber scale following the removal of monochromator

instruments, and addition of slightly shifted band positions for ATR FT-IR

instruments;

· 將單色儀移除後的波數比例尺從7處減少到4處，並增加ATR FT-IR儀器的位移帶位置

· guidance on the use of stored spectra and internal

libraries;

· 關於使用存儲光譜和內部庫指南；

· a description of procedures for the comparison of

spectra.

· 說明光譜分析程序。

It is

highlighted that the new band positions – and the associated acceptable

tolerances – proposed for the verification of the wavenumber scale have been

established based on experimental data gathered during two series of

round-robin tests by different laboratories using different instruments.

值得注意的是，根據不同實驗室使用不同儀器進行的兩輪循環測試系列期間收集的實驗數據，建立了用於驗證波數比例的新波段位置和相關的可接受公差。

原文來源於：國際藥品註冊網&春草夢醫藥

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