NEWS

新聞

06 APRIL 2018

2018.04.06

STRASBOURG, FRANCE

法國(guó)，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(huì)第160次大會(huì)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(jié)是藥典方法的基礎(chǔ)之一，在許多基礎(chǔ)文本和1200多個(gè)人專著中均有引用。

The chapter ha ** een completely rewritten and its structure updated to include:

該章節(jié)已經(jīng)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(shí)，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(shù)對(duì)傅里葉變換光譜儀(ft-IR)進(jìn)行了進(jìn)一步描述，并給出了設(shè)備性能控制的相關(guān)標(biāo)準(zhǔn)；

· a new "principle" section, with distinctionbetween near-, mid- and far-infrared;

· 新的“原則”部分，區(qū)分近紅外、中紅外和遠(yuǎn)紅外；

· new sections on applications and limitations;

· 新設(shè)有關(guān)使用和限制章節(jié)；

· 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(shù)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(guān)于使用存儲(chǔ)光譜和內(nèi)部庫(kù)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(jù)不同實(shí)驗(yàn)室使用不同儀器進(jìn)行的兩輪循環(huán)測(cè)試系列期間收集的實(shí)驗(yàn)數(shù)據(jù)，建立了用于驗(yàn)證波數(shù)比例的新波段位置和相關(guān)的可接受公差。 原文來源于：國(guó)際藥品注冊(cè)網(wǎng)&春草夢(mèng)醫(yī)藥

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