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Postion:Product Catalog >N-Nitroso Clomipramine EP Impurity F
N-Nitroso Clomipramine EP Impurity F
  • N-Nitroso Clomipramine EP Impurity F
  • N-Nitroso Clomipramine EP Impurity F
  • N-Nitroso Clomipramine EP Impurity F
  • N-Nitroso Clomipramine EP Impurity F
  • N-Nitroso Clomipramine EP Impurity F

N-Nitroso Clomipramine EP Impurity F NEW

Price Get Latest Price
Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-08-01

Product Details

Product Name: N-Nitroso Clomipramine EP Impurity F CAS No.: 78213-40-8
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/08/01
Molecular formula: C14H11ClN2O

N-Nitroso Clomipramine EP Impurity F

Article illustration




  • 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: C??H??ClN?O

  • Molecular Weight: 258.70

  • Advantages

  • As EP Impurity F (nitroso derivative) of Clomipramine, this compound has the following advantages:

  • 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:

  • 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!

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com


Company Profile Introduction

1. Drug standards and drug impurity reference substances: provide more than 20,000 kinds of spot impurity reference substances, with sufficient supply and same-day delivery. We have a professional R&D team and comprehensive quality control testing to ensure product quality and reliability. 2. Customized synthesis of impurities and new molecules: Quickly respond to the customized needs of CDE impurities, stably supply impurities that have established quality standards, and provide customized synthesis services for new compounds in the research and development of innovative drugs. 3. Preparation and separation of unknown impurities: With a professional impurity preparation and separation technical team and SFC preparation and separation instruments, we can solve the problems of impurity preparation in complex projects. 4. Process development of new drug intermediates: provide the supply of new drugs and new molecular impurities, process optimization services, as well as the screening and impurity analysis of commercialization routes. 5. Peptide synthesis: Provide customized peptide synthesis services, and cover all kinds of degradation impurities and process impurities generated in the research and development of peptide drugs. At the same time, it provides comprehensive structural confirmation data and customized testing services.

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