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포함 사항: HPLC, MASS/LC-MS, 1H NMR, FT-IR, 함량, 구조 규명 보고서(SER), 그리고 제품에 따라 추가 분석 데이터가 제공됩니다.

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

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카탈로그 번호:	VE0026669
CAS 번호:	2125944-54-7
분자식:	C22H27FN3NaO6S
분자량:	503.52 g/mol

견적 요청

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모약물

Rosuvastatin

IUPAC명

(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

설명

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.