An impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance specification. A specified impurity can be either identified or unidentified Impurity is defined as any substance coexisting with the original drug, such as starting material or intermediates or that is formed, due to any side reactions. According to the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guideline on impurities in new drug substances, an impurity is defined as ‘any component of the new drug substance that is not the chemical entity defined as the new drug substance’. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. There are different methods for detecting and characterizing impurities with TLC, HPLC, and HPTLC etc. The most exploited techniques, for impurity profiling of drugs are LC-MS-MS, LC-NMR, LCNMR- MS, GC-MS, and LC-MS.
We offers a wide range of high purity Impurity Standards for the pharmaceutical industries on the milligram to kilogram scale at competitive price.
It is recommended to use Impurity Standard having purity Not Less Than (NLT) 90 % when used for peak identification in the chromatogram or use in the system suitability test for resolution and minimum 95.0 % when used to estimate the content of a specified impurity.
The quantification & identification of impurity in the specialty chemicals, bulk chemicals, intermediate and APIs product is carried by using Certified Impurity Standards of known purity.
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