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Stability testing is a routine procedure performed on drug substances and products. It is involved at various stages of product development. In early stages, accelerated stability testing (at relatively high temperatures and/or humidities) can be used as a “worst case” evaluation to determine what types of degradation products may be found after long-term storage. Testing under more gentle conditions (those recommended for long-term shelf storage), and slightly elevated temperatures, can be used to determine a product’s shelf life and expiration dates.
In these types of studies, the product is analyzed at intervals for various parameters, which may include assay of the active ingredient, measurement of known degradation products, dissolution time, appearance, etc. Additionally, samples from production lots of approved products are retained for stability testing in case of product failure in the field. Retained samples can be tested alongside returned samples to ascertain if the problem was manufacturing or storage related.
We has been performing analyses to support our clients’ stability programs for several years. We do not currently have environmental chambers to store samples.
9240 Santa Fe Springs Rd
Santa Fe Springs, CA 90670562.948.2225 Fax 562.948.5850
Formerly West Coast Analytical Service (WCAS) and Bodycote Testing Group
