Norfloxacin EP Impurity E CAS 75001-85-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.75001-85-3
Molecular FormulaC16H18ClN3O3
Molecular Weight335.79 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Norfloxacin EP Impurity E CAS 75001-85-3 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.

CATO supplies Norfloxacin EP Impurity E (CAS 75001-85-3), a pharmacopoeial impurity reference standard (molecular formula C16H18ClN3O3, MW 335.79 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Norfloxacin EP Impurity E is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 335.79 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.

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 FormulaC16H18ClN3O3
Molecular Weight335.79 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1978
Halogen ContentCl-containing
Nitrogen Atoms3

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