Metformin Impurity 16 CAS 598-65-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.598-65-2
Molecular FormulaH2O4S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Metformin Impurity 16 CAS 598-65-2 chemical structure

Description

Structurally, Metformin Impurity 16 (H2O4SC3H9N3) contains an amide group, a sulfone group, a carboxylic acid group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 0.0, corresponding to approximately 0 ring(s) or double-bond equivalent(s). With a molecular weight of 185.20 g/mol, it falls into the medium-molecular-weight range. 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 process- or degradation-related impurity, Metformin Impurity 16 (CAS 598-65-2, H2O4SC3H9N3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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 FormulaH2O4S 2*C3H9N3
Molecular Weight185.20 g/mol
Purity97%+
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)0.0
CAS Registry Year (est.)1957
Nitrogen Atoms3
Sulfur Atoms1

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