Benidipine Impurity 28(Mixture of Diastereomers) CAS 121138-43-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.121138-43-0
Molecular FormulaC27H29N3O6
Molecular Weight491.54 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Benidipine Impurity 28(Mixture of Diastereomers) CAS 121138-43-0 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 Benidipine Impurity 28(Mixture of Diastereomers).

Benidipine Impurity 28(Mixture of Diastereomers) (CAS 121138-43-0) is a certified pharmaceutical impurity reference standard with the molecular formula C27H29N3O6 and a molecular weight of 491.54 g/mol.

The molecular framework of Benidipine Impurity 28(Mixture of Diastereomers) (C27H29N3O6) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. 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.

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 FormulaC27H29N3O6
Molecular Weight491.54 g/mol
AppearancePale yellow to yellow crystalline powder
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
Degree of Unsaturation (DBE)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Nitrogen Atoms3

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