Ketoprofen API for finished dosage formulation – complete guide for buyers
Ketoprofen API is a widely used active pharmaceutical ingredient in the global pharmaceutical industry. Understanding its formulation, quality requirements, and regulatory expectations is essential for API buyers and manufacturers.
1) What is Ketoprofen API?
Ketoprofen is an NSAID used for pain relief and inflammation control. It belongs to the propionic acid class and works by inhibiting COX enzymes responsible for prostaglandin production.
- Chemical name: 2-(3-benzoylphenyl)propanoic acid
- CAS number: 22071-15-4
- White crystalline powder
- Available in USP / EP / BP / IP grades
2) Importance in finished dosage formulation
- Used in tablets, capsules, gels, and patches
- Flexible formulation options
- Suitable for multiple therapeutic applications
- Widely accepted in global markets
3) Mechanism of action
- Blocks COX-1 and COX-2 enzymes
- Reduces prostaglandin production
- Decreases pain, inflammation, and fever
4) Quality standards and specifications
- USP / EP / BP pharmacopoeia compliance
- High purity and controlled impurity limits
- COA, MSDS, and stability data
- GMP-certified manufacturing
5) Formulation strategies
- Immediate and sustained-release tablets
- Topical gels with enhanced absorption
- Transdermal patches for controlled delivery
- Injectable formulations with strict processing
6) Storage and handling
- Store in cool and dry conditions
- Protect from light and moisture
- Use sealed containers
- Maintain batch traceability
7) Regulatory considerations
- DMF and CEP documentation support
- Compliance with global GMP standards
- Export/import regulatory requirements
8) Benefits for API buyers
- Consistent product quality
- Better formulation performance
- Faster regulatory approvals
- Reliable supply chain
9) Conclusion
Ketoprofen API plays a vital role in pharmaceutical formulation. Choosing high-quality API with proper documentation ensures compliance, safety, and effective drug development.
10) Contact us for Ketoprofen API
Looking to source Ketoprofen API? Contact us today for high-quality pharma grade API, competitive pricing, and global delivery support.
Phone: +91 99044 98877 | +91 95580 12935 | +91 91067 95854
Email: mail@globaux.net