Thrust for development of new drug molecules providing knowledge about impurities and its ill effects on human health has gained immense importance. Last decade has witnessed an enormous interest in impurity profiling of drugs in pharmaceutical field. The occurrence of these undesirable chemicals, even in trifling quantity may influence the efficacy and safety of the pharmaceutical products. Many Pharmacopoeias viz United States Pharmacopeia (USP), Indian Pharmacopoeia (IP), and British Pharmacopoeia (BP), European Pharmacopoeia (EU) have designed monographs to ensure minimum acceptable quality of drug substances and drug products for users. The monograph included in pharmacopoeia on impurity profiling is getting critical attention from regulatory authorities.
Our service of impurity profiling includes identification, structure, elucidation and quantitive determination of impurities and degradation products in bulk drug materials and pharmaceuticals formulations.
Our service of impurity profiling includes identification, structure, elucidation and quantitive determination of impurities and degradation products in bulk drug materials and pharmaceuticals formulations.
The impurity profiling is studied with objectives to establish specific link between two or more samples, ascertaining drug distribution pattern, for identification of source of drug sample and also for monitoring the process for drug manufacturing. The health implications of impurities can be significant because of their potential teratogenic, mutagenic, or carcinogenic effects. Identification of pharmaceutical impurities is a critical analytical activity in the drug development process whose goal is to fully elucidate the chemical structure of unknown pharmaceutical impurity present in either drug substances or drug products above a particular threshold