N,N-Dinitroso Clozapine EP Impurity C

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,N-Dinitroso Clozapine EP Impurity C is a highly genotoxic impurity of clozapine, formed when two nitroso groups are introduced into the molecule. Listed in the European Pharmacopoeia, it is strictly controlled at trace levels. Detection and quantification are performed using highly sensitive analytical techniques like LC-MS or HPLC to ensure patient safety and regulatory compliance.

N,N-Dinitroso Clozapine EP Impurity C

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