Category
Clozapine
CAS Number
90353-66-5
Molecular Formula
C13H8ClN3O2
Molecular Weight
273.68g/mol
Synonym

8-Chloro-5-nitroso-5,10-dihydro-11H-dibenzo[b,e][1,4]diazepin-11-one; 11H-Dibenzo[b,e][1,4]diazepin-11-one, 8-chloro-5,10-dihydro-5-nitroso; 8-Chloro-5,10-dihydro-5-nitroso-11H-dibenzo[b,e][1,4]diazepin-11-one; 3-chloro-11-nitroso-5H-benzo[b][1,4]benzodiazepin-6-one

Keywords
Fine Chemicals
Nitrosamine Standards manufacturers and Suppliers in Hyderabad India
Pharmaceutical Standards
Metabolites.
Impurities
Intermediates
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.

N-Nitroso Clozapine EP Impurity A is a genotoxic impurity of clozapine specified in the European Pharmacopoeia. It forms when a nitroso group attaches to clozapine and is strictly limited due to its potential health risks. Regulatory standards require sensitive monitoring, typically using HPLC or LC-MS, to ensure the drug’s safety and compliance.