Detection, synthesis and analysis of pharmaceutical impurities
Detection, synthesis and analysis of pharmaceutical impuritiesIdentifying impurities is the first step in preventing them. By elucidating the structure of impurities, itis possible to understand their formation mechanism, which can then inform industry practice aroundprevention or control.For impurity identification, the components of the drug must be separated to isolate any...
The Origin of Impurities in Pharma
Impurities in pharmaceutical products can compromise both the safety and efficacy of drugs, makingtheir identification and control a critical aspect of drug development and manufacturing. Theseimpurities can arise at any stage of drug formulation and are broadly categorized into threetypes: organic impurities, inorganic impurities, and residual solvent impurities. Understandinghow these...
Identifying impurities
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
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,...