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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.

463962-56-3Simvastatin acyl-b-D-glucuronide

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카탈로그 번호:	VE0026547
CAS 번호:	463962-56-3
분자식:	C31H48O12
분자량:	612.7 g/mol

견적 요청

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모약물

Simvastatin

IUPAC명

6-[7-[8-(2,2-dimethylbutanoyloxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoyl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid

Pharmacopeial Synonyms

N/A

동의어

N/A

SMILES

CC1C=C2C(C(CCC(O)CC(CC(OC3OC(C(O)=O)C(O)C(O)C3O)=O)O)C(C)C=C2)([H])C(OC(C(C)(CC)C)=O)C1

InChI

InChI=1S/C31H48O12/c1-6-31(4,5)30(40)41-21-12-15(2)11-17-8-7-16(3)20(23(17)21)10-9-18(32)13-19(33)14-22(34)42-29-26(37)24(35)25(36)27(43-29)28(38)39/h7-8,11,15-16,18-21,23-27,29,32-33,35-37H,6,9-10,12-14H2,1-5H3,(H,38,39)

설명

Simvastatin acyl-b-D-glucuronide (CAS 463962-56-3) is a known process and metabolic impurity of simvastatin that requires targeted monitoring during API synthesis and stability studies. This impurity exhibits increased polarity relative to simvastatin, complicating extraction and chromatography; typical identification and quantitation employ LC-MS and HPLC with gradient methods and authentic reference standards. Control strategies focus on optimizing esterification and limiting glucuronidation, validated cleaning and impurity fate studies. Regulatory risk assessment follows ICH Q3A and Q3B principles to define reporting, identification and qualification thresholds, while forced degradation studies clarify its impact on drug substance purity and shelf life.