Metformin EP Impurity E Sulfate CAS 36801-25-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.36801-25-9
Molecular FormulaC3H9N5
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Metformin EP Impurity E Sulfate CAS 36801-25-9 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, Metformin EP Impurity E Sulfate (CAS 36801-25-9, C3H9N5H2O4S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C3H9N5H2O4S, Metformin EP Impurity E Sulfate contains an amide group, a sulfone group, a carboxylic acid group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 213.21 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

As a certified reference material (CRM), Metformin EP Impurity E Sulfate meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC3H9N5 H2O4S
Molecular Weight213.21 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1967
Nitrogen Atoms5
Sulfur Atoms1

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