Sodium Valproate Impurity 43 CAS 4440-07-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.4440-07-7
Molecular FormulaC8H14O4
Molecular Weight174.19 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sodium Valproate Impurity 43 CAS 4440-07-7 chemical structure

Description

Sodium Valproate Impurity 43 (CAS 4440-07-7) is a certified pharmaceutical impurity reference standard with the molecular formula C8H14O4 and a molecular weight of 174.19 g/mol.

The molecular framework of Sodium Valproate Impurity 43 (C8H14O4) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development.

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 FormulaC8H14O4
Molecular Weight174.19 g/mol
Purity>95%
StorageStore at 2-8°C, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1958

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