Gatifloxacin Impurity 4 CAS 103460-89-5

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.103460-89-5
Molecular FormulaC18H19F2N3O3
Molecular Weight363.36 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gatifloxacin Impurity 4 CAS 103460-89-5 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 363.36 g/mol gives Gatifloxacin Impurity 4 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Gatifloxacin Impurity 4 (CAS 103460-89-5), a pharmacopoeial impurity reference standard (molecular formula C18H19F2N3O3, MW 363.36 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Gatifloxacin Impurity 4 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 363.36 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.

As a certified reference material (CRM), Gatifloxacin Impurity 4 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC18H19F2N3O3
Molecular Weight363.36 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>90%
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1986
Halogen ContentF-containing
Nitrogen Atoms3

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