Ciprofloxacin EP Impurity E（HCl） CAS 105394-83-0(Free Base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.105394-83-0(Free Base)
Molecular FormulaC16H18FN3O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ciprofloxacin EP Impurity E（HCl） CAS 105394-83-0(Free Base) chemical structure

Description

The occurrence of Ciprofloxacin EP Impurity E（HCl） is closely related to a nitrogen-containing heterocyclic scaffold, 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.

Ciprofloxacin EP Impurity E（HCl） (CAS 105394-83-0(Free Base)) is a certified pharmaceutical impurity reference standard with the molecular formula C16H18FN3OHCl and a molecular weight of 323.80 g/mol.

Ciprofloxacin EP Impurity E（HCl） (C16H18FN3OHCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 FormulaC16H18FN3O HCl
Molecular Weight323.80 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Cl-containing
Nitrogen Atoms3

Related Ciprofloxacin Standards

Recommended Standards

Why CATO?