Metformin Impurity 38 CAS 118632-64-7

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.118632-64-7
Molecular FormulaC4H10N4O
Molecular Weight130.15 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Metformin Impurity 38 CAS 118632-64-7 chemical structure

Description

The occurrence of Metformin Impurity 38 is closely related to an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Metformin Impurity 38 (CAS 118632-64-7) is a certified pharmaceutical impurity reference standard with the molecular formula C4H10N4O and a molecular weight of 130.15 g/mol.

Metformin Impurity 38 (C4H10N4O) contains an amide group, a hydroxyl group, an ether linkage. 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 FormulaC4H10N4O
Molecular Weight130.15 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1990
Nitrogen Atoms4

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