Terbinafine Impurity 13 HCl CAS CATO-C4X-133850

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-133850
Molecular FormulaC15H16ClN
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Terbinafine Impurity 13 HCl CAS CATO-C4X-133850 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Terbinafine Impurity 13 HCl.

As a process- or degradation-related impurity, Terbinafine Impurity 13 HCl (CAS CATO-C4X-133850, C15H16ClNHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C15H16ClNHCl, Terbinafine Impurity 13 HCl contains a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 282.21 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC15H16ClN HCl
Molecular Weight282.21 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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