Diclofenac Sodium

Diclofenac Sodium

Parameter Specification
Product Name Diclofenac Sodium
CAS Number 15307-79-6
Molecular Formula C14H10Cl2NNaO2
Molecular Weight 318.13 g/mol
Appearance White to off-white crystalline powder
Assay (HPLC) 99.0% - 101.0% (on dried basis)
Solubility Sparingly soluble in water, freely soluble in ethanol, slightly soluble in acetone
Particle Size NLT 98% through 80 mesh
Package 25 kg fiber drum with double polyethylene liner

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Diclofenac Sodium Structure

Synonyms: Diclofenac sodium salt, Voltaren, Cataflam, 2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium salt, GP 45840, Diclofenac natrium

Diclofenac sodium is a phenylacetic acid derivative that functions as a nonsteroidal anti-inflammatory drug (NSAID). Its molecular structure features a 2,6-dichlorophenylamino group attached to a benzeneacetic acid moiety, with the sodium salt enhancing aqueous solubility. The compound exerts its therapeutic effects primarily through inhibition of cyclooxygenase (COX) enzymes, thereby reducing the synthesis of prostaglandins, which are key mediators of inflammation, pain, and fever.

Commercially, diclofenac sodium is produced via a multi-step synthesis starting from 2,6-dichloroaniline and phenylacetic acid derivatives. The final product is obtained as a white to off-white crystalline powder, meeting pharmacopeial standards such as USP, EP, and BP. It is available in various grades, including micronized and sustained-release forms, to suit different formulation needs.

As a widely prescribed NSAID, diclofenac sodium is used in oral, topical, and injectable dosage forms for the management of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute pain conditions. Its established efficacy and safety profile make it a staple in both human and veterinary medicine. Ongoing research explores its potential in combination therapies and novel drug delivery systems to improve patient compliance and reduce gastrointestinal side effects.

Chemical Structure & Properties

Diclofenac sodium is the sodium salt of 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid. It has a molecular weight of 318.13 g/mol and appears as a white to off-white crystalline powder. The compound is sparingly soluble in water, freely soluble in ethanol, and slightly soluble in acetone. Its melting point range is typically between 283°C and 285°C (with decomposition). The presence of the sodium ion makes it more water-soluble than the free acid form, facilitating formulation into aqueous solutions.

Mechanism of Action

  • COX inhibition: Diclofenac sodium non-selectively inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), enzymes responsible for converting arachidonic acid to prostaglandin H2, a precursor of prostaglandins and thromboxanes.
  • Prostaglandin suppression: By blocking COX, it reduces the production of prostaglandins, which are involved in pain, inflammation, and fever.
  • Leukotriene modulation: Diclofenac may also shift arachidonic acid metabolism towards the lipoxygenase pathway, increasing leukotriene synthesis, although the clinical relevance is not fully established.
  • Neutrophil function: It inhibits neutrophil chemotaxis and superoxide production, contributing to its anti-inflammatory effects.

Quality Specifications (QC Tests)

Test Item Specification
Identification IR spectrum conforms to reference standard
Loss on Drying Not more than 0.5%
Heavy Metals Not more than 10 ppm
Related Substances Total impurities ≤ 0.5%, individual ≤ 0.2%
Microbial Limits Total aerobic count ≤ 1000 CFU/g, Yeast & Mold ≤ 100 CFU/g, E. coli absent

Supply & Documentation

  • Capacity: 50 metric tons per year
  • Lead time: 3-5 business days (stock items)
  • Documentation: COA, MSDS, TDS, DMF available upon request
  • Packaging: 25 kg fiber drum with double polyethylene liner, or as per customer requirements

Frequently Asked Questions

What is the minimum order quantity (MOQ) for Diclofenac Sodium?

Our standard MOQ is 25 kg. For smaller quantities, please contact us to discuss your specific needs.

What is the delivery time?

For stock items, delivery is typically 3-5 business days after order confirmation.

Can you provide a COA and samples?

Yes, we provide a COA for each batch. Samples are available upon request, typically shipped within 1-2 days.

Contact & Ordering Information

  • Company: LyvBio Co., Ltd.
  • Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
  • Email: info@lyvbio.com
  • Phone: +86-29-65816888

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