Cimetidine impurity 28 CAS 95010-84-7

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.95010-84-7
Molecular FormulaC6H10N2O2
Molecular Weight142.16 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cimetidine impurity 28 CAS 95010-84-7 chemical structure

Description

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.

As a process- or degradation-related impurity, Cimetidine impurity 28 (CAS 95010-84-7, C6H10N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Cimetidine impurity 28 (C6H10N2O2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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).

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 FormulaC6H10N2O2
Molecular Weight142.16 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1984
Nitrogen Atoms2

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