A Detailed Overview of Fluvoxamine Impurities: EP, USP and Global Guidelines
At Chemicea Pharmaceutical, we specialize in delivering high-quality pharmaceutical reference standards, including a comprehensive range of Fluvoxamine impurities. These impurities are synthesized and characterized in compliance with international pharmacopeial guidelines, such as the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other global standards.
Fluvoxamine, a well-known selective serotonin reuptake inhibitor (SSRI), is used to treat conditions such as obsessive-compulsive disorder (OCD) and depression. Ensuring the purity, stability, and efficacy of Fluvoxamine is crucial, and managing impurities is essential in maintaining product quality and regulatory compliance.
What Are Fluvoxamine Impurities?
Fluvoxamine impurities refer to substances that can form during manufacturing, storage, or degradation. These impurities can impact the drug’s purity and efficacy, and must be identified, controlled, and minimized to meet pharmacopeial standards.
How Fluvoxamine Impurities Impact Pharmaceutical Quality
Impurities in Fluvoxamine can arise from various sources, such as synthesis by-products, degradation products due to environmental factors, or inconsistencies during production. Proper identification and management of these impurities are vital to maintaining the drug’s quality, safety, and efficacy, ensuring compliance with EP, USP, and other regulatory standards.
Fluvoxamine Structure
Fluvoxamine Chemical Details
- CAS Number: 54739-18-3
- Chemical Formula: C15H21F3N2O2
- Molecular Weight: 318.34 g/mol
- IUPAC Name: (E)-5-methoxy-N-[2-(trifluoromethyl)phenyl]pentanamide
- Synonyms:
- Luvox
- Dumirox
- Favoxil
These chemical details form the foundation for understanding Fluvoxamine's synthesis, stability, and potential impurities, ensuring compliance with pharmacopeial standards.
The Chemistry of Fluvoxamine
Fluvoxamine is an SSRI that increases serotonin levels in the brain, making it highly effective for treating OCD and depression. However, its chemical structure, featuring a trifluoromethyl group, also presents challenges in managing potential impurities during the drug’s synthesis and storage.
Understanding the chemistry of Fluvoxamine is key to identifying impurities and ensuring that the drug meets global regulatory guidelines.
Pharmaceutical Applications of Fluvoxamine
- Primary Use: Fluvoxamine is used to treat OCD, depression, and anxiety disorders.
- Off-Label Uses: It has also been explored for potential benefits in treating COVID-19.
The purity and stability of Fluvoxamine are essential to its success in these applications. Controlling impurities ensures that Fluvoxamine remains safe, effective, and compliant with global pharmacopeial standards.
Fluvoxamine and Its Impurities Tree Diagram
Understanding Fluvoxamine Impurities
Impurities in Fluvoxamine can be classified into three main categories:
- Degradation Impurities: Formed when Fluvoxamine is exposed to heat, light, or pH changes during storage.
- Process Impurities: By-products resulting from incomplete or side reactions during synthesis.
- Potential Impurities: Hypothetical impurities predicted based on the synthetic pathway and degradation mechanisms.
Managing these impurities is essential for maintaining the stability and efficacy of the drug. At Chemicea Pharmaceutical, we offer high-quality reference standards to help pharmaceutical companies ensure compliance with EP, USP, and global guidelines.
Key Fluvoxamine Impurities Offered by Chemicea
At Chemicea Pharmaceutical, we provide an extensive range of Fluvoxamine impurities. These impurities are critical for quality control, stability testing, and method development in pharmaceutical research. Below is a list of key Fluvoxamine impurities, arranged alphabetically:
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CAT No. |
Impurity Name |
CAS Number |
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NA |
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These impurities are monitored and controlled to ensure product consistency and meet stringent regulatory standards.
Classification and Description of Fluvoxamine Impurities
1. Fluvoxamine EP Impurity A (CAS No. 1217216-82-4)
Type: Process Impurity
Description: By-product of synthesis resulting from side reactions.
Role: Used for process optimization and product consistency.
2. Fluvoxamine EP Impurity B (CAS No. 89035-92-7)
Type: Degradation Impurity
Description: Forms under prolonged exposure to environmental conditions.
Role: Important for stability testing and ensuring shelf life.
3. Fluvoxamine EP Impurity C (CAS No. 259526-43-7)
Type: Process Impurity
Description: Results from incomplete synthesis reactions.
Role: Monitored to improve process control.
4. Fluvoxamine EP Impurity D (CAS No. 61718-80-7)
Type: Process Impurity
Description: A by-product due to suboptimal reaction conditions.
Role: Ensures product quality and consistency.
5. Fluvoxamine EP Impurity E (CAS No. 1217214-94-2)
Type: Potential Impurity
Description: Hypothetical impurity predicted during synthesis.
Role: Important for impurity profiling and quality control.
6. Fluvoxamine EP Impurity F (CAS No. NA)
Type: Degradation Impurity
Description: Forms due to environmental factors like heat or light exposure.
Role: Used in stability testing to ensure product efficacy over time.
7. Fluvoxamine EP Impurity G (CAS No. 192876-02-1)
Type: Process Impurity
Description: A by-product of the synthesis process.
Role: Monitored for process control and product quality.
8. Fluvoxamine EP Impurity J (CAS No. 1217241-15-0)
Type: Potential Impurity
Description: Hypothetical impurity predicted based on synthesis conditions.
Role: Ensures comprehensive impurity profiling for product safety.
How Chemicea Helps Ensure Quality
At Chemicea Pharmaceutical, we provide certified reference standards for Fluvoxamine impurities, helping pharmaceutical companies maintain regulatory compliance and meet the highest quality standards. By utilizing our expertise in impurity profiling and synthesis, we ensure that your products are safe, effective, and fully compliant with international standards.
Conclusion and Call to Action
Managing Fluvoxamine impurities is crucial for maintaining the quality, safety, and efficacy of pharmaceutical products. Chemicea Pharmaceutical provides the expertise and certified reference standards needed to support your quality control and regulatory compliance efforts.
For more information on our Fluvoxamine impurities or to explore our comprehensive product catalog, contact our team today. We are committed to supporting your pharmaceutical development and ensuring your products meet the highest industry standards.
