Gemfibrozil Impurity 11 CAS 31264-51-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.31264-51-4
Molecular FormulaC11H15ClO
Molecular Weight198.69 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gemfibrozil Impurity 11 CAS 31264-51-4 chemical structure

Description

CATO supplies Gemfibrozil Impurity 11 (CAS 31264-51-4), a pharmacopoeial impurity reference standard (molecular formula C11H15ClO, MW 198.69 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Gemfibrozil Impurity 11 (C11H15ClO) contains a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 198.69 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC11H15ClO
Molecular Weight198.69 g/mol
Purity>95%
StorageStore at 2-8°C, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1965
Halogen ContentCl-containing

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