Sitafloxacin Isomer Impurity 8(RSS) HCl CAS CATO-C4X-115561

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-115561
Molecular FormulaC19H18ClF2N3O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitafloxacin Isomer Impurity 8(RSS) HCl CAS CATO-C4X-115561 chemical structure

Description

The occurrence of Sitafloxacin Isomer Impurity 8(RSS) HCl is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Sitafloxacin Isomer Impurity 8(RSS) HCl (CAS CATO-C4X-115561), a pharmacopoeial impurity reference standard (molecular formula C19H18ClF2N3O3HCl, MW 446.27 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C19H18ClF2N3O3HCl, Sitafloxacin Isomer Impurity 8(RSS) HCl contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 446.27 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

As a certified reference material (CRM), Sitafloxacin Isomer Impurity 8(RSS) HCl 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 FormulaC19H18ClF2N3O3 HCl
Molecular Weight446.27 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Cl-containing
Nitrogen Atoms3

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