Gemcitabine Impurity 25 CAS 166275-25-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.166275-25-8
Molecular FormulaC5H6F2O4
Molecular Weight168.10 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gemcitabine Impurity 25 CAS 166275-25-8 chemical structure

Description

Based on its molecular formula C5H6F2O4, Gemcitabine Impurity 25 contains a carbohydrate-derived structure, fluorine substitution; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 168.10 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

Gemcitabine Impurity 25 (CAS 166275-25-8) is a certified pharmaceutical impurity reference standard with the molecular formula C5H6F2O4 and a molecular weight of 168.10 g/mol.

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 FormulaC5H6F2O4
Molecular Weight168.10 g/mol
Purity>95%
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)2.0
CAS Registry Year (est.)2004
Halogen ContentF-containing

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