Sitafloxacin impurity 84 CAS 1533823-99-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1533823-99-2
Molecular FormulaC13H20N2
Molecular Weight204.31 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitafloxacin impurity 84 CAS 1533823-99-2 chemical structure

Description

Sitafloxacin impurity 84 (CAS 1533823-99-2) is a certified pharmaceutical impurity reference standard with the molecular formula C13H20N2 and a molecular weight of 204.31 g/mol.

Sitafloxacin impurity 84 (C13H20N2) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC13H20N2
Molecular Weight204.31 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1992
Nitrogen Atoms2

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