Enalapril EP Impurity H Hydrochloride(Mixture of Diastereomers) CAS CATO-C4X-13349

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-13349
Molecular FormulaC20H34N2O5
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Enalapril EP Impurity H Hydrochloride(Mixture of Diastereomers) CAS CATO-C4X-13349 chemical structure

Description

As a certified reference material (CRM), Enalapril EP Impurity H Hydrochloride(Mixture of Diastereomers) 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.

Enalapril EP Impurity H Hydrochloride(Mixture of Diastereomers) (CAS CATO-C4X-13349) is a certified pharmaceutical impurity reference standard with the molecular formula C20H34N2O5HCl and a molecular weight of 418.96 g/mol.

The molecular framework of Enalapril EP Impurity H Hydrochloride(Mixture of Diastereomers) (C20H34N2O5HCl) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. 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. 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.

Physical & Chemical Properties

Molecular FormulaC20H34N2O5 HCl
Molecular Weight418.96 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore in a cool place (≤25°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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms2

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