Polaprezinc Impurity 13 DiHCl CAS CATO-C4X-182113

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-182113
Molecular FormulaC9H14N4O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Polaprezinc Impurity 13 DiHCl CAS CATO-C4X-182113 chemical structure

Description

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.

Polaprezinc Impurity 13 DiHCl (CAS CATO-C4X-182113) is a certified pharmaceutical impurity reference standard with the molecular formula C9H14N4O3HCl and a molecular weight of 262.69 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Polaprezinc Impurity 13 DiHCl is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 262.69 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

Physical & Chemical Properties

Molecular FormulaC9H14N4O3 2*HCl
Molecular Weight262.69 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms4

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