Category
Atorvastatin
CAS Number
2588261-36-1
Molecular Formula
C₃₇H₄₄N₂O₅
Molecular Weight
596.8 g/mol
Synonym

Tert-butyl (3R,5R)-3,5-dihydroxy-7-(2-isopropyl-4,5-diphenyl-3-(phenylcarbamoyl)-1H-pyrrol-1-yl)heptanoate; (3R,5R)-tert-butyl3,5-dihydroxy-7-(2-isopropyl-4,5-diphenyl-3- (phenylcarbamoyl)-1H-pyrrol-1-yl)heptanoate

Keywords
Fine Chemicals
Pharmaceutical Standards
Metabolites.
Impurities
Intermediates
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Atorvastatin Impurity 10 is a process-related impurity formed during the manufacture of Atorvastatin calcium, used to treat hyperlipidemia and reduce cardiovascular risk. It may arise during synthesis or through degradation and is carefully monitored to remain within pharmacopeial limits. It has a CAS Number of 2588261-36-1, molecular formula of C₃₇H₄₄N₂O₅, molecular weight of 596.8 g/mol. It is analyzed according to standards set by the European Pharmacopoeia and the United States Pharmacopeia, ensuring compliance with International Council for Harmonisation guidelines and regulatory authorities like the U.S. Food and Drug Administration and the European Medicines Agency. Its monitoring is essential for impurity profiling, stability studies, and method validation.

Manasa Life Sciences, based in Hyderabad, supplies high-purity Atorvastatin Impurity 10 with full traceability and GDP compliance. The company also offers impurity profiling, risk assessment, and analytical method development using HPLC and LC-MS, helping manufacturers meet global regulatory standards and ensure product safety.