Catégorie
Apalutamide
Numéro CAS
1332391-92-0
Formule moléculaire
C21H15F4N5O3
Masse moléculaire
461.4 g/mol
Synonyme

4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dioxo-5,7-diazaspiro[3.4]octan-5-yl]-2-fluoro-N-methylbenzamide; 4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-6,8-dioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluoro-N-methylbenzamide; Apalutamide Dioxo Impurity; Apalutamide Di keto impurity; 4-[7-[6-Cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide

Mots-clés
Intermediates
Impurities
Metabolites.
Pharmaceutical Standards
Fine Chemicals
slide.1
Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

6,8-Dioxo Apalutamide is an oxidative impurity or degradation product of apalutamide, formed by oxidation at the 6 and 8 positions of the molecule, and is monitored as part of pharmaceutical quality control to ensure the safety, stability, and purity of apalutamide drug substance and finished dosage forms.