Istradefylline Impurity 17 (Mixture of Diastereomers) CAS CATO-C4X-106117

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-106117
Molecular FormulaC40H50N8O8
Molecular Weight770.87 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Istradefylline Impurity 17 (Mixture of Diastereomers) CAS CATO-C4X-106117 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 Istradefylline Impurity 17 (Mixture of Diastereomers).

CATO supplies Istradefylline Impurity 17 (Mixture of Diastereomers) (CAS CATO-C4X-106117), a pharmacopoeial impurity reference standard (molecular formula C40H50N8O8, MW 770.87 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Istradefylline Impurity 17 (Mixture of Diastereomers) (C40H50N8O8) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 20.0, corresponding to approximately 20 ring(s) or double-bond equivalent(s). With a molecular weight of 770.87 g/mol, it falls into the high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

As a certified reference material (CRM), Istradefylline Impurity 17 (Mixture of Diastereomers) meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC40H50N8O8
Molecular Weight770.87 g/mol
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)20.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms8

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