Empagliflozin impurity 01 CAS 95574-97-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.95574-97-3
Molecular FormulaC4H7ClO3
Molecular Weight138.55 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Empagliflozin impurity 01 CAS 95574-97-3 chemical structure

Description

The occurrence of Empagliflozin impurity 01 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Empagliflozin impurity 01 (CAS 95574-97-3, C4H7ClO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Empagliflozin impurity 01 is typically white to off-white liquid. Its solid-state physicochemical attributes — including a molecular weight of 138.55 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC4H7ClO3
Molecular Weight138.55 g/mol
Purity97%+
StorageStore at 2-8°C, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityHygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1984
Halogen ContentCl-containing

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