Category
Clozapine
CAS Number
NA
Molecular Formula
C30H22Cl2N8O2
Molecular Weight
597.5g/mol
Synonym

1,4-Bis(8-chloro-5-nitroso-5H-dibenzo[b,e][1,4]diazepin-11-yl)piperazine; 3-chloro-6-[4-(3-chloro-11-nitrosobenzo[b][1,4]benzodiazepin-6-yl)piperazin-1-yl]-11-nitrosobenzo[b][1,4]benzodiazepine

Keywords
Impurities
Metabolites.
Pharmaceutical Standards
Intermediates
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 EP Impurity B is another genotoxic impurity of clozapine listed in the European Pharmacopoeia. Like Impurity A, it forms through nitrosation of clozapine and is strictly controlled due to its toxic potential. Detection is typically carried out using sensitive analytical methods such as HPLC or LC-MS to ensure drug safety and regulatory compliance.