权威医学用药书籍速查系统

ANNEX Japanese Pharmacopoeia (JP):

This test is harmonized with the European Pharmacopoeia and the U . S . Pharmacopeia . The parts of the text that are not harmonized are marked with symbols ( ◆ ◆ ) .The preparation complies with the test if the average number of particles present in the units tested does not exceed 3000 per container equal to or greater than 10 μ m and does no exceed 300 per container equal to or greater than 25 μ m .

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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 TEST FOR PARTICULATE CONTAMINATION: SUB-VISIBLE PARTICLES GENERAL CHAPTER Q4B ANNEX 3(R1) > EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REG
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:298-309
版本:1
出版时间:2011-01-01
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