Chlorhexidine Digluconate EP Impurity E CAS 45964-97-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.45964-97-4
Molecular FormulaC7H8ClN3
Molecular Weight169.61 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Chlorhexidine Digluconate EP Impurity E CAS 45964-97-4 chemical structure

Description

The occurrence of Chlorhexidine Digluconate EP Impurity E is closely related to a nitrile group, chlorine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Chlorhexidine Digluconate EP Impurity E (CAS 45964-97-4, C7H8ClN3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Chlorhexidine Digluconate EP Impurity E (C7H8ClN3) is characterized by a nitrile group, chlorine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

As a certified reference material (CRM), Chlorhexidine Digluconate EP Impurity E meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC7H8ClN3
Molecular Weight169.61 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1970
Halogen ContentCl-containing
Nitrogen Atoms3

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