Rosuvastatin (6S)-Isomer (Sodium Salt)
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2125944-54-7Rosuvastatin (6S)-Isomer (Sodium Salt)

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Catalogue No.:VE0026669
CAS No.:2125944-54-7
Mol. Formula:C22H27FN3NaO6S
Mol. Weight:503.52 g/mol

Additional information on CAS 2125944-54-7

Parent drug

Rosuvastatin

IUPAC Name

(3R,5S)-5-[(S)-8-Fluoro-4-isopropyl-2-(N-methylmethylsulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl]-3,5-dihydroxypentanoic Acid Sodium Salt

Smiles

CC(C)C1=NC(N(S(C)(=O)=O)C)=NC2=C1C[C@@]([C@@H](O)C[C@@H](O)CC([O-][Na+])=O)([H])C3=C2C=CC(F)=C3

InChI

InChI=1S/C22H28FN3O6S.Na/c1-11(2)20-17-10-16(18(28)8-13(27)9-19(29)30)15-7-12(23)5-6-14(15)21(17)25-22(24-20)26(3)33(4,31)32;/h5-7,11,13,16,18,27-28H,8-10H2,1-4H3,(H,29,30);/q;+1/p-1/t13-,16+,18+;/m1./s1

Description

Rosuvastatin (6S)-Isomer (Sodium Salt) impurity, CAS 2125944-54-7, is characterized as a stereochemical and process-related variant that can arise from incomplete stereoselective synthesis, epimerization or degradation during downstream processing and storage. Analytical control requires orthogonal techniques such as chiral HPLC or UPLC, LC-MS for mass confirmation, and NMR for stereochemical assignment to ensure accurate identification and quantitation. This impurity impacts assay, potency and impurity profiles and is typically monitored and controlled in specifications in line with ICH Q3A/B guidance, with limits established through toxicological qualification and manufacturing root cause analysis to minimize formation.

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