权威医学用药书籍速查系统

2. Q4B OUTCOME

The ICH Steering Committee , based on the evaluation by the Q4B Expert Working Group ( EWG ) , recommends that the official pharmacopoeial texts , Ph . Eur . 20414 Sulphated Ash JP 2.44 Residue on Ignition Test , and USP & lt .Residue on Ignition can be used as interchangeable in the ICH region given the following : 2.1.1 Unless otherwise specified in a monograph , an appropriate sample weight is chosen , typically 1-2g .The proposed texts evaluated did not contain acceptance criteria .

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——《2011药品注册的国际技术要求.质量部分》
书名:《2011药品注册的国际技术要求.质量部分》
栏目:2011药品注册的国际技术要求.质量部分 > EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON RESIDUE ON IGNITION/SULPHATED ASH GENERAL CHAPTER Q4B ANNEX 1(R1) > EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON RESIDUE ON IGNIT
作者:美国ICH指导委员会 周海钧
参编:王执,王知坚,匡荣,李洋,张洁
页码:283
版本:1
出版时间:2011-01-01
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