Impurities

Qualification of the impurities is the process of acquiring and evaluating data that establishes biological safety of an individual monograph or dug Substance. Impurity standards thus revealing the need and scope of Impurity profiling of drugs in Pharmaceutical Research

We have subject matter experts, who are engaged in the synthesis of impurities and metabolites of active pharmaceutical ingredients which include antibiotics, steroids, chiral, achiral drugs and deuterated compounds. The subject matter experts possess core skills in reaction design, complex synthesis, purification, analysis and characterization.

Identification and synthesis of New Degradants and Impurities

In addition to its wide range of existing standards, Pharmaffiliates has considerable expertise in the identification and synthesis of new and challenging degradants and impurities. Pharmaffiliates 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

Pharmaffiliates understands the needs of industry. Our certified standards are shipped with a Certificate of Analysis, MSDS and all the required documentation to ensure statutory domestic and international reputations. Our standards are of high purity, scientifically characterized. Our laboratory and quality systems have successfully passed audits by major pharmaceutical companies, four largest manufacturers among them.

We have over 8500 standards available in ready stock. Each Impurity Standard,working standard is provided with its Certificate of Analysis, Chromatographic purity, Infra-red spectra, NMR spectra etc with interpretation.

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