Validation of a generic analytical procedure for determination of residual solvents in drug substances-Reference-Cited by-同舟云学术

Validation of a generic analytical procedure for determination of residual solvents in drug substances

Published:2004-10 Issue:2 Volume:36 Page:401-409
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Klick Silke,Sköld Agneta

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference12 articles.

1. Proceedings of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Tripartite harmonised guideline Q3C “Impurities: Residual Solvents”, 1997.

2. Head-space analysis in modern gas chromatography

3. European Pharmacopeia 4th Edition (2.4.24), Identification and Control of Residual Solvents, Council of Europe, Strasbourg, France, 2002.

4. United States Pharmacopeia XXVII <467>, Organic Volatile Impurities, 2004.

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