Clopidogrel Impurity 59 CAS 40412-09-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.40412-09-7
Molecular FormulaC13H14O3S2
Molecular Weight282.38 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clopidogrel Impurity 59 CAS 40412-09-7 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Clopidogrel Impurity 59.

Clopidogrel Impurity 59 (CAS 40412-09-7) is a certified pharmaceutical impurity reference standard with the molecular formula C13H14O3S2 and a molecular weight of 282.38 g/mol.

Clopidogrel Impurity 59 (C13H14O3S2) contains a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 FormulaC13H14O3S2
Molecular Weight282.38 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1968
Sulfur Atoms2

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