Sodium Cyclamate EP Impurity D CAS 101-83-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.101-83-7
Molecular FormulaC12H23N
Molecular Weight181.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sodium Cyclamate EP Impurity D CAS 101-83-7 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 Sodium Cyclamate EP Impurity D.

As a process- or degradation-related impurity, Sodium Cyclamate EP Impurity D (CAS 101-83-7, C12H23N) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Sodium Cyclamate EP Impurity D (C12H23N) is characterized by a nitrile group. 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.

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.

CATO manufactures Sodium Cyclamate EP Impurity D under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC12H23N
Molecular Weight181.32 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1957
Nitrogen Atoms1

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