Sotagliflozin Impurity 2 CAS 1327165-94-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1327165-94-5
Molecular FormulaC21H25ClO7
Molecular Weight424.87 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sotagliflozin Impurity 2 CAS 1327165-94-5 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 Sotagliflozin Impurity 2.

CATO supplies Sotagliflozin Impurity 2 (CAS 1327165-94-5), a pharmacopoeial impurity reference standard (molecular formula C21H25ClO7, MW 424.87 g/mol) used for the identification and quantification of trace impurities in APIs.

Sotagliflozin Impurity 2 (C21H25ClO7) contains a flavonoid core, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, 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 FormulaC21H25ClO7
Molecular Weight424.87 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentCl-containing

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