Dissolution/Degradation Products – Stress Testing

A drug product, even before its expiration date, may form degradation products that are toxic to humans. Besides stability studies, used to determine the product expiration date, studies that identify possible degradation products, that may affect the consumers safety, must also be performed. FORCED DEGRADATION studies in drugs and pharmaceutical resources follow all requirements of regulation RDC 58/2012 from ANVISA, in which degradation conditions are simulated: ACID, BASE, OXIDATION, TEMPERATURE, HUMIDITY AND LIGHT.

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