Loperamide EP Impurity A CAS 1391052-94-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1391052-94-0
Molecular FormulaC35H37ClN2O2
Molecular Weight553.13 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Loperamide EP Impurity A CAS 1391052-94-0 chemical structure

Description

CATO supplies Loperamide EP Impurity A (CAS 1391052-94-0), a pharmacopoeial impurity reference standard (molecular formula C35H37ClN2O2, MW 553.13 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Loperamide EP Impurity A (C35H37ClN2O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 18.0, corresponding to approximately 18 ring(s) or double-bond equivalent(s). With a molecular weight of 553.13 g/mol, it falls into the moderately-high-molecular-weight range. 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 Loperamide EP Impurity A 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 FormulaC35H37ClN2O2
Molecular Weight553.13 g/mol
AppearancePale yellow to 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)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentCl-containing
Nitrogen Atoms2

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