Fludarabine Phosphate Impurity 11 CAS CATO-C4X-184611

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-184611
Molecular FormulaC10H12FN4O8P
Molecular Weight366.20 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fludarabine Phosphate Impurity 11 CAS CATO-C4X-184611 chemical structure

Description

The occurrence of Fludarabine Phosphate Impurity 11 is closely related to a carbohydrate-derived structure, an amide group, a phosphate ester group, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Fludarabine Phosphate Impurity 11 (CAS CATO-C4X-184611, C10H12FN4O8P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Fludarabine Phosphate Impurity 11 (C10H12FN4O8P) contains a carbohydrate-derived structure, an amide group, a phosphate ester group, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 6.5, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 366.20 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

CATO manufactures Fludarabine Phosphate Impurity 11 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC10H12FN4O8P
Molecular Weight366.20 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
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)6.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms4

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