Amlodipine Besylate EP Impurity H CAS 318465-73-5

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.318465-73-5
Molecular FormulaC28H29ClN2O8
Molecular Weight556.99 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Amlodipine Besylate EP Impurity H CAS 318465-73-5 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 556.99 g/mol gives Amlodipine Besylate EP Impurity H distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Amlodipine Besylate EP Impurity H (CAS 318465-73-5, C28H29ClN2O8) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Amlodipine Besylate EP Impurity H is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 556.99 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC28H29ClN2O8
Molecular Weight556.99 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>90%
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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentCl-containing
Nitrogen Atoms2

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