Meglumine impurity 6 CAS 62137-31-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.62137-31-9
Molecular FormulaC7H16N2O6
Molecular Weight224.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Meglumine impurity 6 CAS 62137-31-9 chemical structure

Description

Structurally, Meglumine impurity 6 (C7H16N2O6) contains a carbohydrate-derived structure, an amide group. The molecule exhibits a degree of unsaturation (DBE) of 1.0, corresponding to approximately 1 ring(s) or double-bond equivalent(s). With a molecular weight of 224.21 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, Meglumine impurity 6 (CAS 62137-31-9, C7H16N2O6) 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 FormulaC7H16N2O6
Molecular Weight224.21 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.)1974
Nitrogen Atoms2

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