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For our clients to keep up with regulations for stability indicating methods, DYNALABS offers validation extensions for client specific products.
The Validation Extension process is performed on each active contained in a specific product.
A Validation Extension consist of performing specificity and method precision for a specific product.
Method precision: the sample is prepared 6 times to the target range of the method and injected on a qualified HPLC. The %RSD of the 6 injection needs to be less than %RSD capability of the method.
Specificity: A set of placebos are held for a 24-hour incubation. One placebo is held at room temperature and the other placebo is held at 70 C. (UV exposure can be included, if applicable) After the 24-hour incubation each placebo is prepared as the release sample for testing. The room temperature placebo is used to ensure that the matrix components do not interfere with the active peak. The heated placebo ensures degradants or extractables are not created and interfering with the active peak.
Per USP <797> the minimum amount of testing to release injectables is Potency by stability indicating method, USP <85> Endotoxin Testing, Sterility Testing and Visual Inspection/Description of Product. DYNALABS understanding of cGMP the following test should also be performed for release testing for injectables at minimum.
USP <788> Testing – Subvisible particle testing
USP <791> pH
USP <71>
Preservative Assay (if applicable to client’s product)
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