Description & Specifications
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Impurity profile studies play significant roles in active pharmaceutical ingredient (API) development, which are closely related to the quality, safety and efficacy of drug products. And the impurity profile of API for drug products requires studying in the view of stringent quality standards. The recent guidelines published by International Conference on Harmonization (ICH) recommended identification and characterization of all the impurities present at a level of ~0.10% or more. Regulatory agencies give significant importance to quantifying the impurities present in the drug substance and also in the drug product. Hence impurities standards are required in pure form. BOC Sciences has a great deal of experience in impurities synthesis services and our professional experts can provide high-quality services for our clients. |