N-Nitroso Clozapine EP Impurity D CAS CATO-C4X-134017

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-134017
Molecular FormulaC18H20ClN5O2
Molecular Weight373.84 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

N-Nitroso Clozapine EP Impurity D CAS CATO-C4X-134017 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 N-Nitroso Clozapine EP Impurity D.

CATO supplies N-Nitroso Clozapine EP Impurity D (CAS CATO-C4X-134017), a pharmacopoeial impurity reference standard (molecular formula C18H20ClN5O2, MW 373.84 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C18H20ClN5O2, N-Nitroso Clozapine EP Impurity D contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 373.84 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 N-Nitroso Clozapine 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 FormulaC18H20ClN5O2
Molecular Weight373.84 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms5

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