Bromfenac Impurity 35 CAS CATO-C4X-200235

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-200235
Molecular FormulaC15H9BrNNaO5
Molecular Weight386.13 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bromfenac Impurity 35 CAS CATO-C4X-200235 chemical structure

Description

Bromfenac Impurity 35 (CAS CATO-C4X-200235) is a certified pharmaceutical impurity reference standard with the molecular formula C15H9BrNNaO5 and a molecular weight of 386.13 g/mol.

Owing to a salt form, a flavonoid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution, Bromfenac Impurity 35 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 386.13 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), Bromfenac Impurity 35 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 FormulaC15H9BrNNaO5
Molecular Weight386.13 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)11.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing
Nitrogen Atoms1

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