Guidelines and strategy of the International Conference of Harmonization (ICH) and its member states to overcome existing impurity control problems for antibiotics in China

Author:

JIANG Yu,XIA Jun-Ping,YANG Jian-Hong,ZHANG Zhe-Feng,HU Chang-Qin,ZHANG Zhi-Rong

Publisher

Elsevier BV

Subject

Complementary and alternative medicine,Drug Discovery,General Medicine

Reference51 articles.

1. EMA. Guideline on setting specifications for related impurities in antibiotics (2010) [S].

2. Setting specifications for antibiotics and synthetic peptides. International symposium organized by the EDQM (2006) [S];New Impurities Control;Council of Europe,2006

3. Reflection on strategy and methods on trace unstable impurities of β-lactam antibiotics [J];Hu;Chin J New Drug,2013

4. Isomeric impurity research and quality control of β-lactam antibiotics [J];Jiang;Chin J Antibiotics,2010

5. Impurity profiling of acetylspiramycin by liquid chromatography-ion trap mass spectrometry [J];Wang;J Chromatogr A,2010

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