Impurities

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Profiling and controlling impurities level and their side pharmaceutical effects is crucial in both drug development and manufacturing process as they may affect the efficacy and safety of APIs, and then lead to failure in developing a potential drug or meeting the quality standard in production. BOC Sciences manufactures thousands of pharmaceutical impurities, degradations, metabolites of active pharmaceutical ingredients, and excipients in accordance with the guidelines and limits described in the international pharmacopeia monographs for many impurities to serve drug development. In particular, BOC Sciences has access to rarely found degradations preparation standards for a number of OTC pharmaceuticals, which enables us to manufacture many degradations with ease; and occasionally we share the standards with our clients all over the world.

In addition to its wide range of existing standards, BOC Sciences has considerable expertise in the identification and synthesis of new and challenging impurities and metabolites. We can provide expert advice on the mechanism of impurities formation and on modifications of formulations to reduce their levels. Synthesis of multi-gram quantities of impurities for toxicity testing is also available to assist your product development.

At BOC Sciences, our top priority is to ensure the quality of our products, and thus the batch purity and uniformity is always guaranteed to be of the highest standards, which are of high purity, thoroughly characterized, and prepared in accordance with BOC Sciences’ robust quality system. Additionally, every compound delivered by BOC Sciences is accompanied with a copy of Specification Sheet or a Certificate of Analysis (COA), MSDS and all the required documentation to ensure a smooth customs clearance. During the past decade, our laboratory and quality systems have successfully passed audits by four of the world's largest pharmaceutical companies.

• Providing high quality impurities and metabolites to satisfy any quantity required
• Impurity isolation from API or drug products by Preparative HPLC
• Identification and synthesis of impurities and metabolites • Expanding our range of standards in response to requests from customers
• Competitive quality and price comparable to commodity chemical suppliers

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