Gliclazide EP Impurity D CAS 1136426-19-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1136426-19-1
Molecular FormulaC15H20N2O3S
Molecular Weight308.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gliclazide EP Impurity D CAS 1136426-19-1 chemical structure

Description

The molecular framework of Gliclazide EP Impurity D (C15H20N2O3S) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Gliclazide EP Impurity D (CAS 1136426-19-1) is a certified pharmaceutical impurity reference standard with the molecular formula C15H20N2O3S and a molecular weight of 308.40 g/mol.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC15H20N2O3S
Molecular Weight308.40 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
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.)1989
Nitrogen Atoms2
Sulfur Atoms1

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