The manufacture of pharmaceuticals, personal care products or cosmeticsrequire that the identity, purity, and quality of raw materials be established through the use of suitable test methods. Pharmacopeial and formulary monographs such as the US Pharmacopeia–National Formulary (USP–NF), the European Pharmacopeia (EP), and the Japanese Pharmacopeia (JP) provide standardized test methods for the most common and widely used active ingredients, excipients and raw materials. The ability to analyze active ingredients, excipients and raw materials requires a wide range of analytical chemistry expertise. While the most common tests performed include titrations, loss on drying, Karl Fisher moisture determination, infrared spectrophotometry, more advance testing is now required by many of these monographs.
Since 1992, Quantex has provided testing for excipients, raw materials and active pharmaceutical ingredients employing compendial methods.Our analytical team has an extensive and proven track record of performing the testing of raw materials using compendial methods, as well as methods supplied by raw materials manufacturers. Over the ensuing years, we have continued to expand upon our capabilities, our knowledge and experience. Our laboratories are equipped with state of the art instruments that allow Quantex to performance the extensive chemical testing required to qualify active ingredients, excipients and raw materials .We offer a full suite of chemistry-based testing which includes excipients and active API’s according to current USP, NF, FCC, EP and JP compendial methods.
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