A long‐time stability study of 50 drug substances representing common drug classes of pharmaceutical use-Reference-Cited by-同舟云学术

A long‐time stability study of 50 drug substances representing common drug classes of pharmaceutical use

Published:2019-05-02 Issue:7 Volume:11 Page:1065-1075
ISSN:1942-7603
Container-title:Drug Testing and Analysis
language:en
Short-container-title:Drug Test Anal

Author:

Zilker Markus¹,Sörgel Fritz²³,Holzgrabe Ulrike¹^ORCID

Affiliation:

1. Institute for Pharmacy and Food ChemistryUniversity of Würzburg Würzburg Germany

2. IBMP ‐ Institute for Biomedical and Pharmaceutical Research Nürnberg‐Heroldsberg Germany

3. Institute of PharmacologyUniversity of Duisburg‐Essen Essen Germany

Publisher

Wiley

Subject

Spectroscopy,Pharmaceutical Science,Environmental Chemistry,Analytical Chemistry

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/dta.2593

Reference25 articles.

1. International Conference on Harmonisation (ICH).Good manufacturing practice guide for active pharmaceutical ingredients Q7.2000. available at:http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf[17 December 2018].

2. European Medicines Agency (EMA).ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients ‐ questions and answers.2015. available at:http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/ICH_Q7‐IWG_QA_v5_0_14Apr2015_FINAL_for_publication_17June2015.pdf[17 December 2018].

3. Sigma‐Aldrich.Product dating information statement.2016. available at:https://www.sigmaaldrich.com/content/dam/sigma‐aldrich/docs/Sigma‐Aldrich/General_Information/1/product‐dating‐information‐statement.pdf[17 December 2018].

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