Ertugliflozin impurity 31 CAS CATO-C4X-301131

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-301131
Molecular FormulaC29H31ClO7
Molecular Weight527.01 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ertugliflozin impurity 31 CAS CATO-C4X-301131 chemical structure

Description

Ertugliflozin impurity 31 (CAS CATO-C4X-301131) is a certified pharmaceutical impurity reference standard with the molecular formula C29H31ClO7 and a molecular weight of 527.01 g/mol.

Based on its molecular formula C29H31ClO7, Ertugliflozin impurity 31 contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, a polycyclic aromatic system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 527.01 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

As a certified reference material (CRM), Ertugliflozin impurity 31 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 FormulaC29H31ClO7
Molecular Weight527.01 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing

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