Gemcitabine EP Impurity C-13C-15N2 CAS 1233921-75-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1233921-75-9
Molecular FormulaC8[13C]H10F2[15N]2O5
Molecular Weight267.16 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gemcitabine EP Impurity C-13C-15N2 CAS 1233921-75-9 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 267.16 g/mol gives Gemcitabine EP Impurity C-13C-15N2 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Gemcitabine EP Impurity C-13C-15N2 (CAS 1233921-75-9), a pharmacopoeial impurity reference standard (molecular formula C8[13C]H10F2[15N]2O5, MW 267.16 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Gemcitabine EP Impurity C-13C-15N2 (C8[13C]H10F2[15N]2O5) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC8[13C]H10F2[15N]2O5
Molecular Weight267.16 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)4.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990
Halogen ContentF-containing
Nitrogen Atoms1

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