Risk evaluation of impurities in topical excipients: The acetol case-Reference-Cited by-同舟云学术

Risk evaluation of impurities in topical excipients: The acetol case

Published:2014-10 Issue:5 Volume:4 Page:303-315
ISSN:2095-1779
Container-title:Journal of Pharmaceutical Analysis
language:en
Short-container-title:Journal of Pharmaceutical Analysis

Author:

Boonen Jente,Veryser Lieselotte,Taevernier Lien,Roche Nathalie,Peremans Kathelijne,Burvenich Christian,De Spiegeleer Bart

Funder

Institute for the Promotion of Innovation through Science and Technology in Flanders (IWT-Vlaanderen)

Special Research Fund (BOF) of Ghent University to Lien Taevernier

Publisher

Elsevier BV

Subject

Analytical Chemistry,Electrochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Pharmacy

Reference70 articles.

1. European Pharmacopoeia 7.5. ed., 2012; 01/20012:1000 General notices. European Directorate for the Quality of Medicines and Healthcare, Strassbourg, France, 2010–2013.

2. Drug excipients;Kalasz;Curr. Med. Chem.,2006

3. EMA, ICH Topic Q3C (R4) Impurities: Guideline for Residual Solvents Step 5, CPMP/ICH/283/95, 2009. 〈http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002674.pdf〉.

4. EMA, Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product. EMEA/CHMP/QWP/396951/2006, 2006. 〈http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003428.pdf〉.

5. Handbook of Pharmaceutical Excipients;Rowe,2003

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