With our capabilities and innovative synthetic strategies and advanced techniques, we are able to design multi-step synthesis faster & cheaper by reducing costs & delivery times.
The impurity standards are important for impurity profiling of drugs in pharmaceutical research and drug development. Identification, isolation and characterization of impurities significantly help in evaluation of biological safety of drug substances.
We also focus in the areas of chemical, medical research & pharmaceutical development of lead compound / prodrug development.
In peptide purification, RP-HPLC chromatography, flash chromatography, ion-exchange chromatography, hydrophobic interaction chromatography, gel filtration chromatography, size exclusion chromatography, and hydrophilic interaction chromatography are commonly used methods.
Impurities may be found in a sample during a manufacturing process or a stability study for an Active Pharmaceutical Ingredient (API) or drug product. Impurities may arise as degradation products, as intermediates/process impurities originating from the synthetic route, as unwanted by-products of side reactions or as contamination of the original sample. It is important to isolate and identify impurities that may occur at very low concentrations relative to the API, perhaps as low as 0.05% w/w.
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