Nitrendipine impurity 21 CAS 1195583-65-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1195583-65-3
Molecular FormulaC17H16N2O6
Molecular Weight344.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nitrendipine impurity 21 CAS 1195583-65-3 chemical structure

Description

CATO supplies Nitrendipine impurity 21 (CAS 1195583-65-3), a pharmacopoeial impurity reference standard (molecular formula C17H16N2O6, MW 344.32 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Nitrendipine impurity 21 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 344.32 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

As a certified reference material (CRM), Nitrendipine impurity 21 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.

Physical & Chemical Properties

Molecular FormulaC17H16N2O6
Molecular Weight344.32 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1989
Nitrogen Atoms2

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