Amlodipine EP Impurity E Maleate CAS 400024-12-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.400024-12-6
Molecular FormulaC21H27ClN2O5
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Amlodipine EP Impurity E Maleate CAS 400024-12-6 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 Amlodipine EP Impurity E Maleate.

As a process- or degradation-related impurity, Amlodipine EP Impurity E Maleate (CAS 400024-12-6, C21H27ClN2O5C4H4O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Amlodipine EP Impurity E Maleate (C21H27ClN2O5C4H4O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

CATO manufactures Amlodipine EP Impurity E Maleate 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 FormulaC21H27ClN2O5 C4H4O4
Molecular Weight538.98 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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentCl-containing
Nitrogen Atoms2

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