RAPS

Industry wants clarity on scope of ICH stability testing guideline, timing of studies

Pharmaceutical companies in the US are requesting additional information on how to conduct stability testing for both new and existing drugs in response to the International Council for ...
RAPS

Convergence: New ICH Q1 guideline is ‘one-stop shop’ for stability testing

PITTSBURGH — The new International Council for Harmonisation (ICH) Q1 draft guideline on stability testing of drug substances and drug products is an attempt to revise the current ICH Q1 guideline, ...
GEN

Stable Ground—The Importance of Stability Testing for Custom GMP Reagents

Stability testing is essential in the pharmaceutical and biopharmaceutical industries. These tests are performed to evaluate the stability of drug products under various environmental conditions. Once ...
Nature

Repetitive stability study of remdesivir/cyclodextrin complex on the international space station

Stability assessment of drugs in space is particularly important for future missions. In space there are multiple factors, such as the variability of the conditions (radiation, microgravity, vacuum ...
Nature

Evaluation of color changes during stability studies using spectrophotometric chromaticity measurements versus visual examination

Stability studies are essential to be able to assign an expiration date to medications. Color variation is one of the organoleptic characteristics of actives substances or medications which can ...