Fosfomycin Impurity 28 CAS CATO-C4X-131628

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-131628
Molecular FormulaC16H30NaO14P
Molecular Weight500.36 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fosfomycin Impurity 28 CAS CATO-C4X-131628 chemical structure

Description

The occurrence of Fosfomycin Impurity 28 is closely related to a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Fosfomycin Impurity 28 (CAS CATO-C4X-131628), a pharmacopoeial impurity reference standard (molecular formula C16H30NaO14P, MW 500.36 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Fosfomycin Impurity 28 (C16H30NaO14P) contains a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 500.36 g/mol, it falls into the moderately-high-molecular-weight range.

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 FormulaC16H30NaO14P
Molecular Weight500.36 g/mol
Purity>95%
StorageStore at room temperature, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityStable under recommended storage conditions
Degree of Unsaturation (DBE)2.0

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