Isosorbide Dinitrate Impurity 4 CAS 39813-48-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.39813-48-4
Molecular FormulaC8H11NO7
Molecular Weight233.18 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Isosorbide Dinitrate Impurity 4 CAS 39813-48-4 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 Isosorbide Dinitrate Impurity 4.

As a process- or degradation-related impurity, Isosorbide Dinitrate Impurity 4 (CAS 39813-48-4, C8H11NO7) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Isosorbide Dinitrate Impurity 4 (C8H11NO7) contains a carbohydrate-derived structure, an amide group. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC8H11NO7
Molecular Weight233.18 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
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.)1968
Nitrogen Atoms1

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