Atorvastatin Impurity 42

Atorvastatin Impurity 42 is a process-related impurity of Atorvastatin, playing a critical role in impurity profiling and pharmaceutical quality control. With CAS No. 54016-70-5, molecular formula C₈H₁₄NOS·Br, and molecular weight 172.3 : 79.9 g/mol, it is chemically identified as 3-Ethyl-5-(2-hydroxyethyl)-4-methylthiazol-3-ium bromide. This impurity serves as a reliable analytical reference standard for the detection and quantification of process-related impurities and degradation products. It is fully compatible with advanced analytical techniques such as HPLC, LC-MS/MS, and NMR, enabling accurate impurity identification, stability studies, and method development in compliance with USP, EP, ICH, and FDA regulatory guidelines.

Manasa Life Sciences, a leading manufacturer and supplier based in India, provides high-purity Atorvastatin Impurity 42 to global pharmaceutical markets including Asia, Europe, Africa, the GCC, and the UAE. The company ensures fully characterized reference standards with complete documentation and traceability, following stringent Good Documentation Practices (GDP). Their experienced scientific team supports pharmaceutical companies with impurity profiling, analytical method validation, structure elucidation, and regulatory risk assessment, ensuring the safety, quality, and consistency of atorvastatin drug products.