Meloxicam is a non-steroidal anti-inflammatory drug belonging to the oxicam chemical class, engineered for solid and liquid pharmaceutical dosage forms. The active ingredient functions through selective cyclooxygenase-2 inhibition, regulating inflammatory pathways at the cellular level. Solid-state parameters, including strict particle size distribution profiles and dedicated polymorphic control, are maintained during crystallization to ensure predictable dissolution kinetics and high bioavailability in finished oral formulations.
Technical Specification
|
Parameter |
Specification |
|
International Nonproprietary Name |
Meloxicam |
|
Chemical Name |
4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide |
|
Therapeutic Category |
Non-steroidal Anti-inflammatory Agent |
|
Pharmacopeial Compliance |
EP / USP / JP |
|
Physical Description |
Pale yellow crystalline powder |
|
Solubility Profile |
Practically insoluble in water; slightly soluble in acetone; soluble in dimethylformamide |
|
Storage Requirements |
Store in tightly sealed containers protected from light and moisture at controlled room temperature |
|
Re-test Period |
36 months verified by long-term stability programs |
Quality & Analytical Standards
|
Test Parameter |
Acceptance Criteria |
Analytical Technique |
|
Assay (Dried Basis) |
99.0 percent to 101.0 percent |
High-Performance Liquid Chromatography |
|
Solution Appearance |
Clear and practically colorless |
Spectrophotometry |
|
Related Substances |
Individual impurity maximum 0.10 percent Total impurities maximum 0.5 percent |
High-Performance Liquid Chromatography |
|
Loss on Drying |
Maximum 0.5 percent |
Gravimetric analysis |
|
Sulfated Ash |
Maximum 0.1 percent |
Residue on ignition |
|
Heavy Metals |
Maximum 20 parts per million |
Colorimetric analysis |
|
Residual Solvents |
Ethanol maximum 0.5 percent, Acetone maximum 0.5 percent |
Gas Chromatography |
|
Particle Size Distribution |
d(0.5): 5 micrometers to 15 micrometers (customizable) |
Laser Diffraction |
|
Polymorphic Identity |
Form I (anhydrous crystalline structure) |
X-Ray Powder Diffraction |
Manufacturing Standards
Synthetic Route: Multi-step organic synthesis utilizing fully validated raw materials and established reaction pathways.
Facility Classification: Dedicated synthesis suites operating under strict current Good Manufacturing Practices.
Purification Controls: Closed-system recrystallization and isolation protocols designed to eliminate contamination risks.
In-Process Monitoring: Real-time verification of reaction endpoints, intermediate purity levels, and moisture content.
Production Capacity: Scaled commercial output ranging from multi-kilogram batches to metric ton quantities with robust supply chain continuity.
Regulatory Documentation
Comprehensive documentation available for regulatory filings across major global jurisdictions.
Provided with every commercial delivery detailing complete lot-specific analytical data.
Compliant with international hazard communication standards.
Animal-origin free certification, genotoxic impurity evaluations, elemental impurity assessments, and complete stability packages.
Packaging and Handling
|
Primary Container |
Food-grade double low-density polyethylene bags heat-sealed under laminar flow conditions. |
|
Secondary Container |
Rigid fiber drums equipped with moisture barriers and light protection. |
|
Security Features |
Sequentially numbered tamper-evident seals on all container closures. |
|
Standard Unit |
25 kilogram net weight per fiber drum, with customized packaging options available upon request. |
Pharmaceutical Applications
Oral Solid Dosage Manufacturing: Integrated into compressed tablets and hard gelatin capsules where controlled particle size ensures blend homogeneity and content uniformity.
Chronic Musculoskeletal Management: Utilized in medications formulated for long-term treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
Dissolution Optimization: Form I crystalline structure provides thermodynamic stability and consistent dissolution rates across physiological ranges.
Modified-Release Integration: Compatible with standard pharmaceutical excipients to support extended-release matrix systems and once-daily dosing profiles.
FAQ
Q: What pharmacopeial standards govern this active ingredient?
A: Production and release testing strictly follow current editions of the European Pharmacopoeia and United States Pharmacopeia.
Q: Is regulatory documentation accessible for generic drug filings?
A: Yes, a complete Drug Master File is maintained and accessible for authorized reference to support market registrations.
Q: How is particle size managed for specific formulation needs?
A: Particle dimensions are controlled through specialized milling parameters during final crystallization, verified via laser diffraction analysis.
Q: What batch sizes are available for commercial supply?
A: Commercial manufacturing is executed in multi-hundred-kilogram batches, complemented by sample quantities for analytical evaluation and research trials.
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