Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor utilized for targeted therapeutic management of osteoarthritis, rheumatoid arthritis, and acute pain. As an active pharmaceutical ingredient, it selectively inhibits prostaglandin synthesis via COX-2 pathways, providing anti-inflammatory and analgesic efficacy while minimizing gastrointestinal side effects associated with traditional non-selective nonsteroidal anti-inflammatory drugs. Produced via validated synthetic routes, this API maintains high chemical purity and controlled impurity profiles to meet stringent formulation requirements for solid oral dosage manufacturing.
Product Information
|
Parameter |
Technical Specification |
|
International Nonproprietary Name |
Celecoxib |
|
Chemical Name |
4-[5-(4-methylphenyl)-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide |
|
CAS Number |
169590-42-5 |
|
Molecular Formula |
C17H14F3N3O2S |
|
Molecular Weight |
381.37 g/mol |
|
Chemical Structure |
Diaryl-substituted pyrazole derivative |
|
Therapeutic Category |
Nonsteroidal Anti-inflammatory Drug / COX-2 Inhibitor |
|
Storage Conditions |
Preserve in tight containers, store at controlled room temperature between 15°C and 30°C, protect from moisture and light |
|
Shelf Life |
36 months from the date of manufacture |
Quality & Specification
|
Test Parameter |
Acceptance Criteria |
|
Appearance |
White to off-white crystalline powder |
|
Identification |
Retention time and infrared absorption spectra conform to reference standard |
|
Assay |
98.0% to 102.0% (anhydrous basis) |
|
Melting Range |
157°C to 160°C |
|
Water Content |
Maximum 0.5% |
|
Residue on Ignition |
Maximum 0.1% |
|
Heavy Metals |
Maximum 10 ppm |
|
Individual Impurity |
Maximum 0.10% |
|
Total Impurities |
Maximum 0.50% |
|
Residual Solvents |
Methanol ≤ 3000 ppm, Ethanol ≤ 5000 ppm, Toluene ≤ 890 ppm |
|
Particle Size Distribution |
D90 between 10 µm and 50 µm (micronized grade available upon request) |
Manufacturing & Supply
Production Standard: Controlled synthetic pathways utilizing purified starting materials, followed by multi-stage crystallization.
Purification Process: Controlled solvent recrystallization to eliminate process-related organic residues and inorganic salts.
Drying & Micronization: Vacuum tray drying followed by closed-circuit air jet milling for controlled particle size distribution.
Cleanroom Classification: ISO Class 8 environment for final isolation, milling, and packaging operations.
Batch Capacity: 100 kg to 500 kg per commercial batch with scalable multi-ton annual production volume.
Documentation
Drug Master File: Available for regulatory submission and technical evaluation.
Certificate of Analysis: Issued for every commercial batch detailing exact assay, impurity levels, and physical parameters.
Certificate of Suitability: Available upon formal request and qualification agreement.
Regulatory Dossiers: Complete impurity profiles, residual solvent validation data, genotoxic impurity assessment reports, and stability data covering climatic zones II and IVb.
Compliance Statements: Certified free from Bovine Spongiform Encephalopathy and Transmissible Spongiform Encephalopathy agents, melamine, and elemental impurities conforming to international pharmaceutical guidelines.
Packaging
|
Primary Packaging |
Double-layer pharmaceutical-grade low-density polyethylene bags, heat-sealed. |
|
Secondary Packaging |
Rigid fiber drums with tamper-evident seals. |
|
Moisture Protection |
Food-grade silica gel packets placed between primary and secondary packaging layers. |
|
Standard Net Weight |
25 kg per drum with customizable container options available upon contractual agreement. |
Pharmaceutical Application
Oral Capsule Formulation: Utilized as the active core component in immediate-release capsule formulations for treating acute postoperative pain and chronic musculoskeletal disorders, ensuring uniform content and rapid dissolution rates.
Tablet Formulation: Processed via wet granulation or direct compression techniques for fixed-dose oral tablet production, exhibiting stable compatibility with standard pharmaceutical excipients including lactose monohydrate and microcrystalline cellulose.
Combination Therapy Development: Incorporated into multi-ingredient pain management research pipelines requiring selective COX-2 inhibition with a consistent impurity profile suitable for comparative pharmacokinetic studies.
FAQ
Q: What is the standard batch size for commercial orders?
A: Standard commercial production batches range from 100 kg to 500 kg, with flexible batch splitting available for smaller validation or scale-up requirements.
Q: Is a Drug Master File accessible for regulatory filing?
A: Yes, a comprehensive file is maintained in accordance with current regulatory requirements to support global application submissions.
Q: What is the established shelf life and storage condition?
A: The shelf life is 36 months when stored in tight containers at controlled room temperature between 15°C and 30°C, protected from direct light and moisture.
Q: Can the particle size distribution be customized?
A: Yes, milling parameters can be adjusted during secondary processing to yield customized particle size distributions for direct compression or wet granulation processes.
Q: What analytical methods are provided for quality verification?
A: Complete analytical validation packages, including high-performance liquid chromatography assay methods, impurity testing protocols, and residual solvent detection procedures, are supplied with the technical documentation.
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