Category
Clozapine
CAS Number
NA
Molecular Formula
C17H16ClN5O
Molecular Weight
341.8g/mol
Synonym

8-chloro-11-(4-nitrosopiperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine; N-Nitroso N-Demethyl Clozapine; Nitroso Compound of Clozapine Impurity C; 3-chloro-6-(4-nitrosopiperazin-1-yl)-11H-benzo[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.

Clozapine Nitroso EP Impurity C is a nitrosated impurity of clozapine identified in the European Pharmacopoeia. It is considered potentially genotoxic and is strictly controlled in pharmaceutical products. Analytical methods like HPLC or LC-MS are used to detect and quantify it to ensure the drug’s safety, purity, and compliance with regulatory limits.