福沙匹坦N-苄基杂质(二甲葡胺盐) CAS 2035475-11-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2035475-11-5
Molecular FormulaC24H30FN4O6P
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

福沙匹坦N-苄基杂质(二甲葡胺盐) CAS 2035475-11-5 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including 福沙匹坦N-苄基杂质(二甲葡胺盐).

CATO supplies 福沙匹坦N-苄基杂质(二甲葡胺盐) (CAS 2035475-11-5), a pharmacopoeial impurity reference standard (molecular formula C24H30FN4O6PC7H17NO5, MW 715.71 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of 福沙匹坦N-苄基杂质(二甲葡胺盐) (C24H30FN4O6PC7H17NO5) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, fluorine substitution. 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC24H30FN4O6P C7H17NO5
Molecular Weight715.71 g/mol
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1996
Halogen ContentF-containing
Nitrogen Atoms5

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