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Drug Purity and Composition Analysis
Drug Purity and Composition Analysis
Drug purity and composition analysis is a critical aspect of pharmaceutical quality control, involving the identification, quantification, and characterization of active pharmaceutical ingredients (APIs), impurities, degradation products, and excipients in drug products. Accurate drug purity and composition analysis ensure the safety, efficacy, and consistency of pharmaceutical formulations, helping to meet regulatory requirements and quality standards. Analytical techniques such as chromatography (e.g., high-performance liquid chromatography, gas chromatography), spectroscopy (e.g., infrared spectroscopy, nuclear magnetic resonance spectroscopy), and mass spectrometry are employed to analyze drug purity and composition accurately.
In pharmaceutical manufacturing, drug purity and composition analysis are performed at various stages of drug development and production, including raw material testing, in-process monitoring, and finished product testing. It helps ensure that drug products meet specifications for identity, strength, quality, and purity, minimizing risks associated with impurities, contaminants, and variability in drug formulations. Additionally, drug purity and composition analysis support stability studies, shelf-life determination, and formulation optimization, contributing to the development of safe and effective pharmaceutical products.