N-Nitroso Clomipramine EP Impurity F NEW

N-Nitroso Clomipramine EP Impurity F

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• roduct Information

• Product Number: C102009

• English Name: N-Nitroso Clomipramine EP Impurity F

• English Alias: 3-chloro-5-nitroso-10,11-dihydro-5H-dibenzo[b,f]azepine

• CAS Number: 78213-40-8

• Molecular Formula: C₁₄H₁₁ClN₂O

• Molecular Weight: 258.70

• Advantages

• As EP Impurity F (nitroso derivative) of Clomipramine, this compound has the following advantages:
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• Well-defined with distinct functional groups: Contains dibenzo[b,f]azepine core, 3-chloro substituent, 5-nitroso (-N-NO), and 10,11-dihydro structure. Unlike clomipramine (tricyclic antidepressant with 5-aminomethyl side chain), its nitroso polarity, chlorine electronegativity, and tricyclic hydrophobicity create significant differences, enabling precise differentiation via HPLC/TLC as a specific marker;

• High stability and traceability: Rigid dibenzoazepine structure and stability of chlorine/nitroso ensure stability under dark, low-temperature conditions. As a derivative from 5-amino nitrosation during storage/degradation, it directly reflects amino stability and nitrite exposure, improving impurity tracing accuracy;

• High detection sensitivity: Tricyclic conjugation shows strong UV absorption (250-290nm), combined with m/z 259 [M+H]⁺ enabling ppb-level analysis via LC-MS, compatible with tricyclic antidepressant nitroso impurity systems.

• Applications

• Pharmaceutical quality control: Used as an EP reference standard to quantify N-Nitroso Clomipramine EP Impurity F in APIs, ensuring compliance with EP limits for this nitroso impurity;

• Stability studies: Monitoring impurity levels under varying conditions (pH, light) to assess degradation trends and support shelf-life assurance;

• Impurity profile analysis: Identifying 5-amino nitrosation as a key impurity source to guide process optimization (e.g., nitrite control).

• Background Description

• Clomipramine contains a dibenzo[b,f]azepine 5-amino group, which may undergo nitrosation upon exposure to nitrous acid (e.g., from nitrate reduction), forming 5-nitroso derivatives like N-Nitroso Clomipramine EP Impurity F. Due to potential genotoxicity, it is strictly regulated by EP, with residues affecting clomipramine safety, making detection and control critical for quality assurance.

• Research Status

• Current research focuses on:
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• Analytical method validation: Developing UPLC assays with C18 columns for separation, achieving 0.05 ppb detection limits;

• Nitrosation mechanism: Studying impurity formation kinetics under varying nitrite concentration and pH to clarify 5-amino-to-nitroso conversion pathways;

• Control strategies: Using nitrosation inhibitors (e.g., sulfites) to keep impurity levels below EP limits (<0.01%);

• Toxicity evaluation: Conducting in vitro genotoxicity tests (e.g., chromosome aberration) to assess hazards and support EP limit revisions.

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

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