DICLOFENAC

PRODUCT IDENTIFICATION

CAS NO. 15307-86-5 (Sodium salt)
15307-81-0 (Potassium salt)

DICLOFENAC

EINECS NO. 239-348-5
FORMULA C14H10Cl2NO2·Na,(K)
MOL WT. 318.13 (334.23)

H.S. CODE

 

TOXICITY

 

SYNONYMS Rhumalgan; Volraman; Voltaren; Voltarol;
2[(2,6-dichlorophenyl)amino]benzeneacetic acid;
SMILES

 

CLASSIFICATION

 

PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL STATE White crystalline powder
MELTING POINT  
BOILING POINT

 

SPECIFIC GRAVITY

 

SOLUBILITY IN WATER soluble
pH  
VAPOR DENSITY

 

AUTOIGNITION

 

NFPA RATINGS

Health: 2 Flammability: 0 Reactivity: 0

REFRACTIVE INDEX

 

FLASH POINT

 

STABILITY

Stable under ordinary conditions. Hygroscopic.

GENERAL DESCRIPTION & APPLICATIONS

Diclofenac, derived from benzeneacetic acid, is a NSAID (nonsteroidal anti-inflammatory drug) of cyclooxygenase (COX) inhibitor. It is used for the treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis, and also for a variety of nonrheumatic inflammatory conditions.. It is a yellowish hygroscopic crystalline powder; soluble in alcohols and insoluble in chloroform and in dilute acid. Chemically, it is described as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid. The sodium or potassium salts are soluble in water; administered orally.

Nonsteroidal Antiinflammatory Drugs (NSAIDs); chemically heterogeneous large groups of drugs which suppress inflammation in a manner similar to steroids, but less side effects of sedation, respiratory depression, or addiction than steroids. They are widely used for the treatment of inflammatory disorders and painful conditions such as rheumatoid arthritis, gout, bursitis, painful menstruation, and headache. They are effective in the relief of pain and fever. NSAIDs inhibit the cyclooxygenase (COX) activity resulting in decreased synthesis of prostaglandin, leukotriene and thromboxane precursors such as the ubiquitous enzyme which catalyzes the initial step in the synthesis of prostanoids. Prostanoid is any of a group of C-20 fatty acids complex with an internal five or six carbon rings such as prostaglandins, prostanoic acid, prostacyclins, and thromboxane; derived from arachidonic acid (C-20 polyunsaturated fatty acid with four cis double bonds). The action or the synthesis of prostanoids are involved in the modulation of a variety of pathophysiologic processes including inflammation, hemostasis, thrombosis, cytoprotection,  ulceration, hemodynamics and other the progression of kidney diseases. Thus, NSAIDs as non-selective inhibitors of the cyclooxygenases (both the cyclooxygenase-1 and cyclooxygenase-2 isoenzymes) may have beneficial as well as untoward effects on a variety of human diseases. Low stomach prostanoid levels caused by COX-1 inhibitors can result in ulceration and internal bleeding and perforation. The selective COX-2 inhibitors such as oxicam, meloxicam, and coxibs (celecoxib, rofecoxib, valdecoxib, parecoxib and etoricoxib) do not interfere with COX-1. The most prominent NSAID is aspirin. Nonaspirin NSAIDs can be classified based on chemical structures.

Nonsteroidal Anti-Inflammatory Drugs (NSAID) by chemical structure

  • Carboxylic Acid Groups
    • Salicylates (Acetylsalicylate, Choline salicylate, Diflunisal, Magnesium choline salicylate, Magnesium salicylate, Salsalate)
    • Acetic Acids (Bendazac, Diclofenac, Etodolac, Indomethacin, Ketorolac, Nabumetone, Sulindac, Tolmetin)
    • Propionic acids (Carprofen, Fenoprofen, Flurbiprofen, Ibuprofen, Ketoprofen, Loxoprofen, Naproxen, Naproxen sodium, Oxaprozin, Vedaprofen)
    • Anthranilic acids (Meclofenamic acid, Meclofenamate sodium, Tolfenamic acid)
    • Phenylacetic acids
    • Aminonicotinic acids (Flunixin)
    • Indole Analogs (Indomethacin, Nabumetone, Ketorolac, Etodolac,)
  • Enolic Acid Groups (which doesn't have carboxylic group but acid due to the enolic hydroxy substituent)
    • Pyrazolones (Phenylbutazone, Oxyphenbutazone, Dipyrone, Ramifenazone)
    • Oxicams (Meloxicam, Piroxicam, Tenoxicam)
  • Coxibs
    • Celecoxib, Rofecoxib, Valdecoxib, Parecoxib, Etoricoxib
  • Gold Salts
    • Auranofin, Gold sodium thiomalate, Aurothioglucose

SALES SPECIFICATION (BP/USP)
DICLOFENAC SODIUM

APPEARANCE

White to yellowish crystalline powder

IDENTIFICATION

Complies Test A, B

ASSAY

99.0 - 101.0%

HEAVY METALS

10ppm max

LOSS ON DRYING

0.5% max

DICLOFENAC POTASSIUM

APPEARANCE

White to yellowish crystalline powder

IDENTIFICATION

Complies Test A, B

ASSAY

99.0 - 101.0%

HEAVY METALS

10ppm max

LOSS ON DRYING

0.5% max

TRANSPORTATION
PACKING

 

HAZARD CLASS 6.1 (Packing Group: I)
UN NO. 2811
OTHER INFORMATION
Hazard Symbols: T, Risk Phrases: 25, Safety Phrases: 22-36/37-45
PRICE

Click to open the table