Isosorbide Dinitrate Impurity 15 CAS 551-43-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.551-43-9
Molecular FormulaC6H8N2O8
Molecular Weight236.14 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Isosorbide Dinitrate Impurity 15 CAS 551-43-9 chemical structure

Description

The occurrence of Isosorbide Dinitrate Impurity 15 is closely related to a carbohydrate-derived structure, an amide group in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Isosorbide Dinitrate Impurity 15 (CAS 551-43-9), a pharmacopoeial impurity reference standard (molecular formula C6H8N2O8, MW 236.14 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Isosorbide Dinitrate Impurity 15 (C6H8N2O8) is characterized by a carbohydrate-derived structure, an amide group. 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. 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.

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 FormulaC6H8N2O8
Molecular Weight236.14 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Nitrogen Atoms2

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