Gliclazide Impurity 11 CAS 640-61-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.640-61-9
Molecular FormulaC8H11NO2S
Molecular Weight185.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gliclazide Impurity 11 CAS 640-61-9 chemical structure

Description

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.

Gliclazide Impurity 11 (CAS 640-61-9) is a certified pharmaceutical impurity reference standard with the molecular formula C8H11NO2S and a molecular weight of 185.24 g/mol.

Structurally, Gliclazide Impurity 11 (C8H11NO2S) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. 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 185.24 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a certified reference material (CRM), Gliclazide Impurity 11 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC8H11NO2S
Molecular Weight185.24 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Nitrogen Atoms1
Sulfur Atoms1

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