Pharmaceutical Impurity and Degradant Reference Standards

Epichem produces a wide range of high purity reference standards for the pharmaceutical and agrochemical industries and maintains stocks for immediate delivery to customers. These standards include impurities, degradants, and metabolites of active ingredients (APIs) and excipients. In particular, we stock hard-to-find degradant standards for a number of OTC pharmaceuticals and regularly ship these to customers throughout the world. Epichem also has considerable experience in the synthesis of deuterated and 13C labeled standards. We are continuously expanding our range of standards in response to requests from customers and we are happy to discuss your requirements should the standard you need not be listed in our current catalogue.

Identification and Synthesis of New Degradants and Impurities.

In addition to its wide range of existing standards, Epichem has considerable expertise in the identification and synthesis of new and challenging degradants and impurities. Epichem can provide expert advice on the mechanism of degradant formation and advise on modifications to formulations to reduce their levels. We can synthesise multigram quantities of degradants for toxicity testing and assist with your product development.

Quality & Reliability

Epichem understands the needs of industry. Our standards are shipped with a Certificate of Analysis, MSDS and all the required documentation to ensure a smooth customs clearance. Our standards are of high purity, thoroughly characterised, and prepared in accordance with Epichem's robust quality system. Our laboratory and quality systems have successfully passed audits by four of the world's largest pharmaceutical companies.