Gentamicin Impurity 8 CAS 59751-72-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.59751-72-3
Molecular FormulaC20H41N5O7
Molecular Weight463.57 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gentamicin Impurity 8 CAS 59751-72-3 chemical structure

Description

The occurrence of Gentamicin Impurity 8 is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Gentamicin Impurity 8 (CAS 59751-72-3, C20H41N5O7) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Gentamicin Impurity 8 (C20H41N5O7) is characterized by an amide group, a carboxylic acid 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.

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 FormulaC20H41N5O7
Molecular Weight463.57 g/mol
AppearanceWhite to pale yellow crystalline powder
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1974
Nitrogen Atoms5

Related Gentamicin Standards

Recommended Standards

Why CATO?