Neomycin Sulfate EP Impurity D CAS 18685-97-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.18685-97-7
Molecular FormulaC12H25N3O7
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Neomycin Sulfate EP Impurity D CAS 18685-97-7 chemical structure

Description

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.

As a process- or degradation-related impurity, Neomycin Sulfate EP Impurity D (CAS 18685-97-7, C12H25N3O7HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Neomycin Sulfate EP Impurity D (C12H25N3O7HCl) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC12H25N3O7 3*HCl
Molecular Weight359.80 g/mol
Purity>95%
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1962
Halogen ContentCl-containing
Nitrogen Atoms3

Related Neomycin Standards

Recommended Standards

Why CATO?