Miltefosine Impurity 1 CAS 76392-53-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.76392-53-5
Molecular FormulaC20H44NO4P
Molecular Weight393.54 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Miltefosine Impurity 1 CAS 76392-53-5 chemical structure

Description

As a process- or degradation-related impurity, Miltefosine Impurity 1 (CAS 76392-53-5, C20H44NO4P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C20H44NO4P, Miltefosine Impurity 1 contains an amide group, a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 393.54 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.

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 FormulaC20H44NO4P
Molecular Weight393.54 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)-0.5
CAS Registry Year (est.)1978
Nitrogen Atoms1

Related Miltefosine Standards

Recommended Standards

Why CATO?