Agilent has released a new module for its ChemStation Plus CDS (chromatography data plus) software that falls into compliance with internationally agreed guidelines on short- and long-term stability studies.
The new module, part of the firm's best-selling ChemStation platform, is the first of its kind to provide solution stability calculations defined by the International Conference on Harmonisation. The ICH is a body charged with developing standards for the global pharmaceutical industry in order to make it easier for companies to develop and launch products across the world's major markets without having to duplicate studies.
The new method validation pack (version A.02.01) features advanced statistical calculations and result management in a relational database and is claimed to be the only pharmaceutical software available that supports automated method validation from planning to final reporting according to ICH, Pharmacopoeia and FDA guidelines, including 21 CFR Part 11.
Version A.02.01 supports stability testing of drugs over the short term (24 to 72 hours) and long term (12 to 24 months), according to ICH Q1A and Q2B guidelines.
Stability testing is routinely used to monitor how the quality of pharmaceutical ingredients and products change over time and under different environmental factors, and to develop recommended storage conditions.
The newest revision of the method validation pack is available free to all customers with a valid software update contract.