Fosfomycin Impurity 60 CAS 135578-84-6

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Fosfomycin Impurity 60.

Fosfomycin Impurity 60 (CAS 135578-84-6) is a certified pharmaceutical impurity reference standard with the molecular formula C11H23O3P and a molecular weight of 234.27 g/mol.

Structurally, Fosfomycin Impurity 60 (C11H23O3P) contains a phosphonate group, a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 0.5, corresponding to approximately 0 ring(s) or double-bond equivalent(s). With a molecular weight of 234.27 g/mol, it falls into the medium-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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

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