CAS · 135308-74-6
Product Overview
N-Metyl impurity of Desvenlafaxine is a high-purity pharmaceutical-intermediates supplied for industrial and specialty chemical applications. Contact our team for specifications, packaging options and lead times.
Product Specifications
| Appearance | Off-white powder |
|---|---|
| Purity | 95% min |
| 1H NMR | Conforms |
Applications
The N-methyl impurity of Desvenlafaxine (CAS 135308-74-6) is primarily relevant in pharmaceutical research and quality control rather than as a standalone therapeutic agent. It is studied as a critical synthetic impurity during the manufacturing of Desvenlafaxine, an antidepressant and serotonin-norepinephrine reuptake inhibitor (SNRI). Monitoring and controlling this impurity is essential for ensuring the purity, safety, and efficacy of the final pharmaceutical product. It is also used in analytical method development, including HPLC, LC-MS, and other chromatographic techniques, to quantify trace levels of N-methyl desvenlafaxine in production batches and stability studies. Additionally, it can be used as a reference standard in regulatory compliance testing.
Benefits
The presence of the N-methyl impurity, when properly characterized, provides significant benefits for pharmaceutical quality assurance. Its identification and quantification allow manufacturers to maintain stringent control over drug purity, reducing potential adverse effects associated with impurities. Understanding its formation pathway helps optimize synthetic routes to minimize its generation, enhancing overall yield and safety. Furthermore, the availability of this impurity as a reference material enables the development of robust analytical methods for routine batch testing, stability studies, and regulatory submission, ensuring compliance with pharmacopeial and international guidelines.
Conclusion
The N-methyl impurity of Desvenlafaxine is an important compound in pharmaceutical quality control and analytical research. Its study facilitates the monitoring, quantification, and management of impurities during drug synthesis and production. By supporting safe and compliant manufacturing of Desvenlafaxine, it plays a crucial role in ensuring drug purity, efficacy, and regulatory adherence in the pharmaceutical industry.
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