Category
Chemical Primary Standard
CAS Number
1795791-15-9
Molecular Formula
C₃₃H₃₁FN₂O₅
Molecular Weight
556.6 g/mol
Synonym

9-Fluoro-2,3-dihydro-3-(1-methylethyl)-2-oxo-N-phenyl-1-[2-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1H-dibenz[e,g]indole-3-carboxamide

Keywords
Impurities
Metabolites.
Pharmaceutical Standards
Intermediates
Fine Chemicals
Impurities manufacturer and Suppliers in Hyderabad india
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Atorvastatin Pyrrolidone Phenanthrene Lactone is a complex process-related and degradation impurity of Atorvastatin, formed under specific synthetic and stress conditions. It is significant for impurity profiling and ensures the quality, safety, and consistency of atorvastatin drug substances and formulations. With CAS No. 1795791-15-9, molecular formula C₃₃H₃₁FN₂O₅, and molecular weight 556.6 g/mol, this compound serves as a reliable analytical reference standard for advanced pharmaceutical analysis.

It is compatible with analytical techniques such as HPLC, LC-MS/MS, and NMR, enabling precise identification and quantification of trace-level impurities and degradation products. This impurity is widely used in stability studies, method development, validation, and regulatory submissions, supporting compliance with USP, EP, ICH, and FDA guidelines.

Manasa Life Sciences, a leading manufacturer and supplier based in India, provides high-purity Atorvastatin Pyrrolidone Phenanthrene Lactone to pharmaceutical markets across 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 expert scientific team offers services in impurity profiling, analytical method validation, structure elucidation, and regulatory risk assessment, helping pharmaceutical companies maintain compliance and ensure the safety, efficacy, and quality of atorvastatin-based products.