NEWS

新聞

06 APRIL 2018

2018.04.06

STRASBOURG, FRANCE

法國，斯特拉斯堡

At its 160thsession (March 2018) the Ph. Eur. Commission adopted a new version of one of its ** jor general methods, which has undergone extensive revision. The chapter onInfrared Absorption Spectrophotometry (2.2.24) is one of the originalcornerstones of phar ** copoeial testing, referenced in ** ny general texts andmore than 1200 individual monographs.

在歐洲藥典委員會第160次大會上，采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 ha ** een 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 monochro ** tor instruments as they are nowobsolete;

· 由于單色儀過時，將其移除；

· an extended description of Fourier-transformspectrometers (FT-IR) using attenuated total reflection (ATR) and relatedcriteria for the control of equipment perfor ** nce;

· 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，并給出了設備性能控制的相關標準；

· a new "principle" section, with distinctionbetween 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 verificationof the wavenumber scale following the removal of monochro ** torinstruments, and addition of slightly shifted band positions for ATR FT-IRinstruments;

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

· guidance on the use of stored spectra and internallibraries;

· 關于使用存儲光譜和內部庫指南；

· a description of procedures for the comparison ofspectra.

· 說明光譜分析程序。

It ishighlighted that the new band positions – and the associated acceptabletolerances – proposed for the verification of the wavenumber scale have beenestablished based on experimental data gathered during two series ofround-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，建立了用于驗證波數比例的新波段位置和相關的可接受公差。 原文來源于：國際藥品注冊網&春草夢醫藥

本譯文著作權歸作者所有，非經作者或國際藥品注冊網授權，不得轉載。