Category
Clozapine
CAS Number
156632-03-0
Molecular Formula
C18H18ClN5O
Molecular Weight
355.8g/mol
Synonym

8-Chloro-11-(4-methylpiperazin-1-yl)-5-nitroso-5H-dibenzo[b,e][1,4]diazepine; 5H-Dibenzo[b,e][1,4]diazepine, 8-chloro-11-(4-methyl-1-piperazinyl)-5-nitroso; 3-chloro-6-(4-methylpiperazin-1-yl)-11-nitrosobenzo[b][1,4]benzodiazepine

Keywords
Intermediates
Impurities
Metabolites.
Pharmaceutical Standards
Fine Chemicals
Nitrosamine Standards manufacturers and Suppliers in Hyderabad India
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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 is a potentially genotoxic impurity of clozapine formed when a nitroso group reacts with the drug molecule. Due to its toxicological risk, regulatory guidelines strictly limit its presence in pharmaceutical products. It is monitored using sensitive analytical techniques, such as LC-MS or HPLC, to ensure patient safety and compliance with pharmacopeial standards.