Valproate EP Impurity I CAS 13310-75-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.13310-75-3
Molecular FormulaC8H15N
Molecular Weight125.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Valproate EP Impurity I CAS 13310-75-3 chemical structure

Description

As a process- or degradation-related impurity, Valproate EP Impurity I (CAS 13310-75-3, C8H15N) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Valproate EP Impurity I (C8H15N) contains a nitrile group. Its physicochemical properties are representative of its class; 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.

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 FormulaC8H15N
Molecular Weight125.21 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1960
Nitrogen Atoms1

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