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- Brazil’s ANVISA publishes API stability assays guidelines
Brazil’s ANVISA publishes API stability assays guidelines
Brazil’s National Health Surveillance Agency (ANVISA) this week published a guideline with technical requirements for the stability assays of active pharmaceutical ingredients (APIs) used for conventional drugs, phytotherapeutics, and radiopharmaceuticals. According to the document, these tests are to be carried out for registration or modification filings, and additional studies will be required for imported and bulk goods to guarantee their quality is preserved until the packaging stage.