An impurity in a drug product, that remain with the active pharmaceutical ingredients (APIs), or develop during formulation, or upon aging of both API and the drug product, is any component of the drug product that is not the chemical entity defined as the drug substance or an excipient in the drug product.
The existence of these impurities even in trace amounts may influence the efficacy and safety of the drug product. Therefore, identification and characterization of impurities called Impurity Profiling is now becoming significant critical product quality parameter and getting critical review from regulatory authorities.
International Conference on Harmonization (ICH) has published guidelines for validation methods for analysis of impurities in new drug products, new drug substances, residual solvents & microbiological impurities for registration of pharmaceuticals. Most active pharmaceutical ingredients (API) are produced by organic chemical synthesis. Various components, including residual solvents, trace amounts of inorganic, and organic components can be generated during such a process. Those components remaining in the final API are considered as impurities.
Reliance Rasayan offers a wide range of high purity Impurity Standards for the pharmaceutical industries on milligram to gram scale at competitive price. We have a technical capability to synthesize, isolate and purify the Impurity Standards to their purest form.
We also offer custom synthesis of impurity compounds as on requests.
A drug reference standard is a standardized substance which is used as a measurement base for similar substances. Where the exact active substances of a new drug are not known, a reference standard provides a calibrated level of biological effects against which new preparations of the drug can be compared. Drug reference Standards are highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators.
They are explicitly required in many Pharmacopeial assays and tests done by any Pharmaceutical Company and are provided solely for such use. The quality and accuracy of Reference Standard are essential to the manufacture of quality medicines and foods.
Reliance Rasayan supply a wide range of high-quality drug reference standard supported with analytical data.