Chlorhexidine EP Impurity M 2HCl CAS CATO-C4X-225611

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-225611
Molecular FormulaC22H31ClN10
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Chlorhexidine EP Impurity M 2HCl CAS CATO-C4X-225611 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 507.47 g/mol gives Chlorhexidine EP Impurity M 2HCl distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Chlorhexidine EP Impurity M 2HCl (CAS CATO-C4X-225611, C22H31ClN10HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Chlorhexidine EP Impurity M 2HCl (C22H31ClN10HCl) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 507.47 g/mol, it falls into the moderately-high-molecular-weight range. 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 FormulaC22H31ClN10 2*HCl
Molecular Weight507.47 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at room temperature, 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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms10

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