Istradefylline Impurity 13 CAS 14436-34-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.14436-34-1
Molecular FormulaC4H5N3O2
Molecular Weight127.10 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Istradefylline Impurity 13 CAS 14436-34-1 chemical structure

Description

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.

Istradefylline Impurity 13 (CAS 14436-34-1) is a certified pharmaceutical impurity reference standard with the molecular formula C4H5N3O2 and a molecular weight of 127.10 g/mol.

Structurally, Istradefylline Impurity 13 (C4H5N3O2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 127.10 g/mol, it falls into the low-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

Physical & Chemical Properties

Molecular FormulaC4H5N3O2
Molecular Weight127.10 g/mol
Purity>95%
StorageStore at 2-8°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)4.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1961
Nitrogen Atoms3

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