Sodium Cyclamate EP Impurity D HCl CAS 4693-92-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.4693-92-9
Molecular FormulaC12H23N
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sodium Cyclamate EP Impurity D HCl CAS 4693-92-9 chemical structure

Description

The molecular framework of Sodium Cyclamate EP Impurity D HCl (C12H23NHCl) is characterized by chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

Sodium Cyclamate EP Impurity D HCl (CAS 4693-92-9) is a certified pharmaceutical impurity reference standard with the molecular formula C12H23NHCl and a molecular weight of 217.78 g/mol.

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 FormulaC12H23N HCl
Molecular Weight217.78 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1958
Halogen ContentCl-containing
Nitrogen Atoms1

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