ABOUT STRESS EXPERIMENTS BY DEVELOPING / IMPROVING ANALYTICAL METHODS AND TECHNOLOGY OF DRUG SUBSTANCES AND MEDICINES
Abstract
The main objectives of stress experiments and tests corresponding to them, and also stress experiments for preparation of solutions for check of system suitability of chromatographic systems are in detail considered. Approach for systematization and the analysis of results of stress experiments (stress testing) is offered. This approach is based on use of relative times of peaks of substances and on the special table, which allows resolving overlapping peaks before and after stress tests with high confidence; it is especially important for development and validation of the analytical methods. The table also gives the possibility to correlate peaks of impurity to certain types of negative chemical reactions of decomposition/transformation of drug substances. Recommendations are presented for conducting stress tests, which would be without doubts a great help in practice.
Keywords
stress testing,
stress experiments,
drug substances,
drugs,
medicines,
stability,
methods,
validation
About the Author
N. A. Epshtein
Autonomous Incorporation «STADA PharmDevelopment», JSC «NIZHPHAR»
Russian Federation
Russian Federation
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Review
For citations:
Epshtein N.A. ABOUT STRESS EXPERIMENTS BY DEVELOPING / IMPROVING ANALYTICAL METHODS AND TECHNOLOGY OF DRUG SUBSTANCES AND MEDICINES. Drug development & registration. 2016;(3):118-132. (In Russ.)
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