Category
Atorvastatin
CAS Number
433289-84-0
Alternate CAS Number
433289-83-9(Ca Salt);1516864-05-3(sodium salt)
Molecular Formula
C₃₃H₃₆N₂O₅
Molecular Weight
540.66 g/mol
Catelogue Number
MLS-ATR-RC-A
Synonym

Atorvastatin Calcium Impurity A (Freebase) (As per 35.1 EP Monograph); Desfluoroatorvastatin; (3R,5R)-7-[2,3-Diphenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid; (3R,5R)-3,5-Dihydroxy-7-[2-(1-methylethyl)-4,5-diphenyl-3-(phenylcarbamoyl)-1H-pyrrol1-yl]heptanoic Acid; (3R,5R)-3,5-Dihydroxy-7-[5-(1-methylethyl)-2,3-diphenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]heptanoic Acid; (3R,5R)-3,5-Dihydroxy-7-(2-isopropyl-4,5-diphenyl-3-(phenylcarbamoyl)-1H-pyrrol-1-yl)heptanoic Acid; (3R,5R)-7-[3-(Phenylcarbamoyl)-5-phenyl-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid; Defluoroatorvastatin

Keywords
Fine Chemicals
Pharmaceutical Standards
Intermediates
Chiral standards
Impurity Standards
Impurities
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Atorvastatin Related Compound-A is a process- or synthesis-related impurity associated with atorvastatin, a widely prescribed drug for lowering cholesterol and reducing cardiovascular risk. This impurity arises during the synthesis or processing of atorvastatin and is closely monitored as part of impurity profiling and quality control. With a CAS Number of 433289-84-0; molecular formula of C₃₃H₃₆N₂O₅ and a molecular weight of 540.66 g/mol, its presence is evaluated under ICH guidelines to ensure product purity, safety, and regulatory compliance. Effective control of this impurity is critical for validating manufacturing processes, maintaining product quality, and safeguarding therapeutic efficacy.

Manasa Life Sciences, based in Hyderabad, India, provides high-quality reference standards for Atorvastatin Related Compound-A, serving clients across Asia, Europe, Africa, the GCC, and the UAE. Our offerings include certified reference materials, risk assessment services, and advanced method development using LC-MS/MS and GC-MS for accurate detection, identification, and quantification of process-related impurities. By adhering to Good Documentation Practices (GDP) and supporting USP/ICH compliance, we help ensure reliable delivery, traceability, and patient safety.