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CELECOXIB

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Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor belonging to the class of nonsteroidal anti-inflammatory drugs (NSAIDs). It is widely used for pain relief, inflammation reduction, and management of arthritis without significantly affecting the gastrointestinal tract, making it a preferred alternative to traditional NSAIDs.

At Bluepill Express, we manufacture high-quality Celecoxib API with exceptional purity, particle uniformity, and consistent potency, ensuring superior performance in formulations. Our production follows WHO-GMP, ISO 9001:2015, and cGMP guidelines to meet IP/BP/USP/EP standards for global pharmaceutical markets.

Therapeutic Uses

  • Relief from pain and inflammation in osteoarthritis and rheumatoid arthritis
  • Treatment of ankylosing spondylitis
  • Management of acute pain and primary dysmenorrhea
  • Useful in juvenile idiopathic arthritis
  • Reduces postoperative and musculoskeletal pain

Mechanism of Action

Celecoxib works by selectively inhibiting the cyclooxygenase-2 (COX-2) enzyme, responsible for prostaglandin synthesis during inflammation.
This selective inhibition results in:

  • Decreased inflammation and pain
  • Minimal impact on COX-1 enzyme (thus less gastric irritation and ulcers)
  • Improved tolerability and safety profile compared to traditional NSAIDs

Pharmacological Information

ParameterDetails
Chemical Name4-[5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Molecular FormulaC17H14F3N3O2S
Molecular Weight381.38 g/mol
CAS Number169590-42-5
Therapeutic CategoryNSAID / COX-2 Inhibitor / Analgesic
Pharmacopoeial StandardsIP / BP / USP / EP

Physical & Chemical Properties

PropertyDescription
AppearanceWhite to off-white crystalline powder
OdorOdorless
Melting Point157°C – 159°C
SolubilityPractically insoluble in water, freely soluble in methanol and ethanol
Assay (on dried basis)98.0% – 102.0%
pH (1% suspension)6.0 – 8.0

Technical Specifications

TestSpecification
AppearanceWhite crystalline powder
IdentificationIR / UV / HPLC – Complies
Assay (Purity)98.0% – 102.0%
Loss on Drying≤ 1.0%
Residue on Ignition≤ 0.1%
Related Substances≤ 0.3% (individual), ≤ 0.5% (total)
Heavy Metals≤ 10 ppm
StorageStore below 25°C in airtight containers, away from light and moisture

Applications

  • Used in capsules, tablets, and suspension formulations for pain and inflammation relief
  • Combines well with paracetamol or tramadol for enhanced pain management
  • Formulated for acute and chronic arthritis conditions
  • Ideal for post-surgical pain formulations

Documentation Provided

  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Technical Data Sheet (TDS)
  • Stability Data (ICH guidelines)
  • Drug Master File (DMF) – available upon request

Packaging & Export Details

Packaging TypeNet Weight
HDPE Drum25 kg
Fiber Drum25 kg
LDPE Inner Bag1 kg / 5 kg / 10 kg

Labeling Includes: Product name, batch number, manufacturing & expiry date, net weight, and storage instructions.
Shelf Life: 5 years (stored below 25°C)
Export Markets: Africa, Middle East, Asia, CIS, and South America

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