Simvastatin Impurity 19

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Catalogue No.:	VE0026534
CAS No.:	N/A
Mol. Formula:	C31H51NO5
Mol. Weight:	517.74 g/mol

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Additional information on

Parent drug

Simvastatin

IUPAC Name

[(1S,3R,7S,8S)-8-[(3R,5R)-7-(cyclohexylamino)-3,5-dihydroxy-7-oxoheptyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate

Smiles

CC(C)(CC)C(O[C@H]1C[C@@H](C)C=C2C1[C@@H](CC[C@@H](O)C[C@@H](O)CC(NC3CCCCC3)=O)[C@@H](C)C=C2)=O

InChI

InChI=1S/C31H51NO5/c1-6-31(4,5)30(36)37-27-17-20(2)16-22-13-12-21(3)26(29(22)27)15-14-24(33)18-25(34)19-28(35)32-23-10-8-7-9-11-23/h12-13,16,20-21,23-27,29,33-34H,6-11,14-15,17-19H2,1-5H3,(H,32,35)/t20-,21-,24+,25+,26-,27-,29?/m0/s1

Description

Simvastatin Impurity 19 is a trace-level synthetic or degradation-related impurity monitored during manufacture and stability assessment of simvastatin APIs. It is routinely identified and quantified using stability-indicating HPLC with orthogonal confirmation by LC-MS and NMR to define structure and mass profile. Control strategies focus on process optimization, targeted purification steps and in-process controls to minimize formation, while inclusion in product specifications and accelerated stability studies ensures regulatory compliance with ICH impurity guidance. Analytical characterization supports risk assessment of potential impact on safety and potency and guides corrective actions such as reformulation or antioxidant use to limit generation during storage.