N-Methylpyrrolidone EP Impurity H CAS 1121-07-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1121-07-9
Molecular FormulaC5H7NO2
Molecular Weight113.11 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

N-Methylpyrrolidone EP Impurity H CAS 1121-07-9 chemical structure

Description

N-Methylpyrrolidone EP Impurity H (CAS 1121-07-9) is a certified pharmaceutical impurity reference standard with the molecular formula C5H7NO2 and a molecular weight of 113.11 g/mol.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, N-Methylpyrrolidone EP Impurity H is typically white to pale yellow liquid. Its solid-state physicochemical attributes — including a molecular weight of 113.11 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC5H7NO2
Molecular Weight113.11 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1957
Nitrogen Atoms1

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