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Impurities are unwanted products that remain with active pharmaceutical ingredients (APIs) and medicines. The presence of these impurities even in trace amounts may influence the efficacy and safety of pharmaceutical products. Identification and quantification of these impurities (Impurity Profile) are now becoming an important critical product quality parameter and are getting critical review from regulatory authorities. Because of this, the limit and threshold values for impurities are specified by pharmacopeias and ICH guidelines. Analysis of impurities according to this set of specifications is mandatory for the pharmaceutical product release for human consumption. Impurity Profile study is also incredibly important for market approval and for finished dosage forms from regulatory authorities.
 

The identification and quantification of impurity in pharmaceutical products are carried out by using certified impurity standards of known purity. It is recommended to use an impurity standard of >90% purity when used for peak identification in the chromatogram or use in the system suitability test for resolution, and a minimum of 95% purity when used to estimate the content of a specified impurity.
 

SEINE PHARMA offers a wide range of high purity and impurity standards for pharmaceutical industries on the mg to gram scale at competitive prices. SEINE PHARMA has a technical capability to synthesize, isolate, and purify the impurity standards to their purest form. SEINE PHARMA can also offer the impurity standards from mg to gm scale.
 

SEINE PHARMA offers custom synthesis of mg to gm level of impurity compounds on requests. In case of non-standard impurity, the standard additional study for structure elucidation, characterization, and analytical method validation are also undertaken using elemental analysis and state-of-the-art equipment like; LC-MS, HPLC, 1 H and 13 C NMR, FT-IR.