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Pharmaffiliates recognize that drug safety begins with understanding what lies beyond the active ingredient. The identification, isolation, and characterization of impurities play a vital role in evaluating the biological safety of every pharmaceutical product.
Driven by this responsibility, Pharmaffiliates offers one of the largest collections of impurity reference standards, featuring over 10,000 in-stock impurities and a catalog of 300,000+ compounds to support pharmaceutical research and manufacturing.
Our team of experienced scientists specializes in synthesizing impurities and metabolites of APIs and FPPs, covering a wide range of therapeutic categories, including antibiotics, steroids, chiral and achiral molecules, and deuterated compounds.
Pharmaffiliates delivers trusted expertise and reliable reference materials to support your impurity profiling needs, whether for regulatory submission, method development, or routine quality control.
Impurity profiling refers to the identification, detection, and quantification of impurities present in APIs or drug products to ensure quality, safety and regulatory compliance.
Regulatory authorities including US-FDA, EMA, MHRA and CDSCO require impurity profiling to confirm pharmaceutical safety and global compliance.
We analyze organic impurities, inorganic impurities, elemental impurities, residual solvents, genotoxic impurities (GTIs), degradation impurities and process-related impurities.
Common techniques include HPLC, LC-MS/MS, GC-MS, ICP-MS, NMR, UV spectroscopy and hyphenated analytical techniques.
Yes, Pharmaffiliates offers synthesis, isolation, characterization and reference standards, including custom synthesis for rare impurities.
The impurity profiling data supports global regulatory submissions including DMF, ANDA, NDA, and CEP filings.
Yes, we provide impurity profiling for biologics, peptides and advanced drug substances along with conventional small-molecule pharmaceuticals.
