Degradation and Impurity Analysis of Different Dosage Forms
The safety of the drug is dependent not only on the intrinsic toxicological properties of the active ingredient, but also on the impurities and degradation products that it may contain. One of the most important considerations in the drug discovery process is safety, not only of the drug itself, but also impurities and degradation products. Impurities present in the active pharmaceutical ingredient (API) have to be identified to make sure no mutagenic or toxic substances will be administered to patients. Drug product degradation profiles need to be established to guide stable formulation and provide suitable drug shelf life assessment. The presence of impurities in active ingredients can have a significant impact on the quality, safety and efficacy of pharmaceuticals. Efforts should be made to identify and characterize all unknown impurities in the drug, due to the increasing demand of regulatory agencies to manufacture high-purity drugs. The drug impurity profile is one of the most important issues in modern pharmaceutical analysis during the process of technology development for the production of high-purity substances.
- Weak bases in mixed aqueous and non-aqueous media
- Qualitative and quantitative analysis
- Enantiomeric impurities
- Organic volatile impurities
- Signal impurities
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