Active Pharmaceutical Ingredient (API) impurities may occur as a result of the API manufacturing process or due to the instability of the API itself or in the finished drug product. API impurities may detract from the efficacy of the drug product, or worse, cause significant unintended side effects or pose safety issues.
API impurities may detract from the efficacy of the drug product, or worse, cause significant unintended side effects or pose safety issues.
Impurities in finished product form may be attributed to multiple sources. Process impurities may occur during manufacturing due to unintended side-reactions or contamination in reagents, solvents, catalysts, and excipients. Some impurities may arise over time due to the instability of the API molecule itself.
Forced degradation studies are used to identify likely degradation products of the API itself or in the finished drug product. APIs are subjected to stress conditions of heat, acid, base, and/or light to deliberately break down the chemical structure so the resulting degradants can be identified and measured in future studies. US FDA guidance recommends the reporting of all degradation products present at 0.1% or more.
Stability studies can be conducted to determine whether these degradants occur in finished drug products stored under different common temperature and humidity conditions.
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