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ISP Standards combines a highly experienced team and superior problem-solving skills with state-of-the-art analytical instrumentation to support impurity analysis. Our custom synthesis service can provide complex or commercially unavailable impurities for analysis or internal standards, and our labeled isotopes can facilitate further studies into metabolites in biological systems.While techniques and regulations...

ISP Standards’ expertise can help ensure accurate data for even the most complex impurities.Synthesis of impurities is a useful tool in impurity studies. By matching the spectral and chromatographic profiles for the impurity with that of the synthesized compound, its structure can be verified. The synthesized impurity can then be studied...

Identifying impurities is the first step in preventing them. By elucidating the structure of impurities, it is possible to understand their formation mechanism, which can then inform industry practice around prevention or control.For impurity identification, the components of the drug must be separated to isolate any process contaminants, degradants, or...

ISP Standards also offers extensive analytical services for impurity identification, including quantitative and qualitative analysis, IR and NMR analysis, mass spectrometry (MS) analysis, and purity determination.All pharmaceutical impurities/related compounds are provided with a Certificate of Analysis (CoA) along with complete characterization data like 1H-NMR, IR, MASS, HPLC Purity, etc. On request,...