Gatifloxacin Impurity 36 CAS 1048972-69-5 (free base)

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.1048972-69-5 (free base)
Molecular FormulaC19H22FN3O4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gatifloxacin Impurity 36 CAS 1048972-69-5 (free base) chemical structure

Description

CATO supplies Gatifloxacin Impurity 36 (CAS 1048972-69-5 (free base)), a pharmacopoeial impurity reference standard (molecular formula C19H22FN3O4HCl, MW 411.86 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Gatifloxacin Impurity 36 (C19H22FN3O4HCl) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine 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 FormulaC19H22FN3O4 HCl
Molecular Weight411.86 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity≥95%
StorageStore in a cool place (≤25°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
Halogen ContentF/Cl-containing
Nitrogen Atoms3

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