Neomycin Impurity 13 CAS 58152-23-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.58152-23-1
Molecular FormulaC17H34N4O10
Molecular Weight454.47 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Neomycin Impurity 13 CAS 58152-23-1 chemical structure

Description

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.

CATO supplies Neomycin Impurity 13 (CAS 58152-23-1), a pharmacopoeial impurity reference standard (molecular formula C17H34N4O10, MW 454.47 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Neomycin Impurity 13 (C17H34N4O10) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 454.47 g/mol, it falls into the moderately-high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

Physical & Chemical Properties

Molecular FormulaC17H34N4O10
Molecular Weight454.47 g/mol
AppearanceWhite to pale yellow crystalline powder
Purity>95%
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.)1973
Nitrogen Atoms4

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