Gemcitabine Impurity 17 CAS 95058-92-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.95058-92-7
Molecular FormulaC10H16F2O5
Molecular Weight254.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gemcitabine Impurity 17 CAS 95058-92-7 chemical structure

Description

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, Gemcitabine Impurity 17 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 254.23 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.

CATO supplies Gemcitabine Impurity 17 (CAS 95058-92-7), a pharmacopoeial impurity reference standard (molecular formula C10H16F2O5, MW 254.23 g/mol) used for the identification and quantification of trace impurities in APIs.

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 FormulaC10H16F2O5
Molecular Weight254.23 g/mol
Purity>95%
StorageStore in a cool place (≤25°C), keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1984
Halogen ContentF-containing

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