N-Nitroso Atomoxetine
| CAT. No. | CP-A30010 |
|---|---|
| CAS. No. | NA |
| Mol. F. | C17H20N2O2 |
| Mol. Wt. | 284.35 |
| Stock Status | In Stock |
VIEW COA- Category: Impurity Standards
- Chemical Name: (R)-N-methyl-N-(3-phenyl-3-(o-tolyloxy)propyl)nitrous amide
N-Nitroso Atomoxetine forms during the synthesis or storage of Atomoxetine under conditions involving heat, moisture, or acidity. As part of the nitrosamine category, it is monitored to meet safety standards established by health agencies. Key Points: Formation: Arises from reactions with nitrosating agents during synthesis or storage. Detection: Identified using advanced techniques like GC-MS, LC-MS, and HPLC-MS. Storage: Best stored in cool, dry conditions, protected from light and reactive substances. Compliance: Supplied by Chemicea Pharma as a reference standard for validation and impurity analysis.
N-Nitroso Atomoxetine serves as a reference standard in the pharmaceutical industry, essential for impurity analysis, profiling, and regulatory compliance. It plays a crucial role in analytical method development (AMV), quality control (QC), DMF filings, and ANDA submissions.
FAQ
It is a nitrosamine impurity that can form during the synthesis, storage, or handling of Atomoxetine, commonly used in pharmaceuticals.
It is subject to strict guidelines from regulatory bodies like the FDA and EMA to ensure safe levels in medications.
It forms when Atomoxetine interacts with nitrosating agents, especially under conditions involving heat, moisture, or acidity.
Through the use of appropriate materials, optimized storage conditions, pH control, and routine testing.
Techniques like GC-MS (high sensitivity), LC-MS (accurate measurement), and HPLC-MS (flexible analysis) are employed.
Chemicea provides COA, H-NMR, MASS, HPLC, and TGA reports as standard, with additional reports like CNMR, IR, UV, DEPT, Water content, and CHNS available upon request.
Yes, they meet the standards of USFDA, EMA, ANVISA, TGA, PMDA, and other global health agencies.
N-Nitroso Atomoxetine is stable for shipping at room temperature, with specific storage requirements detailed in the COA.
Yes, both standard and customized pack sizes are available to meet specific client needs.
Chemicea provides N-Nitroso Atomoxetine as a reference standard, aiding in method validation, impurity analysis, and regulatory compliance for quality control.
