In pharmaceutical manufacturing, the importance of high-purity components cannot be overstated. The presence of impurities, especially API-related impurities, can impact the quality, safety, and efficacy of the drugs. The presence of even small amounts of unwanted components can influence the effectiveness and safety of pharmaceutical products. Analytical methods can easily accurately measure the levels of chemical impurities. Methods like mass spectroscopy and gas chromatography detect the presence of impurities and identify the amounts.
Understanding Pharmaceutical Impurities
Pharmaceutical impurities are unwanted chemicals in API (active pharmaceutical ingredients) or drug formulations. These impurities can arise in synthesis or from other sources like reagents, solvents, catalysts, or reactions from by-products. This is why identification, quantification, and control of impurities are crucial.
Purity Enrichment Services in Pharmaceutical Manufacturing
Aral Research offers purity enrichment services for pharmaceutical manufacturing and biologics development. We provide flash chromatography and HPLC service in Ahmedabad to isolate and purify specific compounds from complex mixtures. Our analytical team leverages the latest technology and methodology to perform product characterization and analytical testing to support drug discovery and formulation.
- Preparative Liquid Chromatography: Since the impurities in the drug are present in low quantity, detailed analysis can be done using isolation of impurities. Preparative LC helps to isolate impurities in adequate amounts.
- LCMS: LCMS is a highly sensitive and specific analytical tool that is used to detect, identify, and quantify product impurities. Our LCMS analysis in Ahmedabad allows for the unambiguous identification of unknown traces of impurities.
- Gas Chromatography: GC is a standard analytical tool for the analysis of volatile organic impurities. A combination of GC and mass analysis can be used to identify and quantify residual solvents.
Benefits of Purity Enrichment Services for Pharmaceutical Manufacturing
- Enhance Product Quality: Ensure your products are free from impurities and contaminants and meet quality standards.
- Regulatory Compliance: Our purity enrichment services ensure pharmaceutical companies meet regulatory requirements.
- Safety & Efficacy: Ensures the drugs are of precise quality and safe from usage.
- Consistent Quality: We help contribute to consistency in all batches to maintain drug efficiency.
At Aral Research, we specialize in providing qualitative analytical data with precise interpretation to help clients with research requirements. So whether you are looking for mass analysis, LCMS analysis, lyophilisation, or HPLC/UPLC, we’ve got you covered! Call us to discuss your research requirements.
