Meldonium EP Impurity C CAS 59514-00-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.59514-00-0
Molecular FormulaC7H17N2O2
Molecular Weight161.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Meldonium EP Impurity C CAS 59514-00-0 chemical structure

Description

The molecular framework of Meldonium EP Impurity C (C7H17N2O2) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

Meldonium EP Impurity C (CAS 59514-00-0) is a certified pharmaceutical impurity reference standard with the molecular formula C7H17N2O2 and a molecular weight of 161.22 g/mol.

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 FormulaC7H17N2O2
Molecular Weight161.22 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)0.5
CAS Registry Year (est.)1974
Nitrogen Atoms2

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