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Pharmaceutical Chemistry
Diclofenac Sodium
Formula:
C14H10Cl2NNaO2
GOST/CAS:
CAS 15307-79-6
Diclofenac Sodium is a highly effective Active Pharmaceutical Ingredient (API) belonging to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). It exhibits potent anti-inflammatory, analgesic, and antipyretic properties. Its mechanism of action is based on the non-selective inhibition of cyclooxygenase enzymes (COX-1 and COX-2), leading to the suppression of prostaglandin synthesis. The product is a white to slightly yellowish crystalline powder, sparingly soluble in water. Due to its proven clinical efficacy and excellent physicochemical stability, it serves as an indispensable core raw material for manufacturing a wide range of finished dosage forms (FDF).
Applications
Topical & Semi-Solid Dosage Forms: Used as the primary active ingredient in the formulation of gels, ointments, creams, and transdermal patches designed for localized treatment of musculoskeletal disorders, joint diseases, and muscle pain relief.
Liquid Dosage Forms: Applied in the production of intramuscular injectable solutions (ampoules), as well as in ophthalmology for manufacturing anti-inflammatory eye drops to manage post-operative ocular inflammation.
Solid Oral Dosage Forms: Serves as the fundamental component in the production of oral medications, including immediate-release tablets, capsules, and specialized modified-release forms (such as enteric-coated or extended-release tablets).
Veterinary Medicine: Utilized in manufacturing anti-inflammatory and pain-relief formulations for livestock and companion animals (strictly adjusted according to species-specific dosage requirements).
Key Advantages
High Therapeutic Efficacy: Provides fast, targeted relief from acute pain and effectively suppresses inflammatory cascades, establishing it as a "gold standard" among NSAIDs in rheumatology and orthopedics.
Process Versatility: Excellent physicochemical stability allows for seamless integration into diverse manufacturing lines—ranging from standard wet granulation for tableting to the preparation of stable emulsions and micellar gels.
Exceptional Purity Profile: Strictly controlled levels of related substances and heavy metals (in full compliance with international pharmacopoeias) ensure maximum safety of the finished drug and minimize adverse reaction risks.
Long-Term Stability: Highly resistant to hydrolysis and thermal degradation under standard processing environments, guaranteeing that the finished pharmaceutical products retain their stated shelf life.
Storage & Transportation
- Store in dry, clean, and cool warehouse environments in tightly sealed original packaging. Keep protected from direct sunlight and away from heat sources.
- Recommended storage temperature: +15°C to +25°C (in strict compliance with international guidelines for active pharmaceutical ingredient storage).
- Protect from excessive ambient humidity due to the material's slight hygroscopic nature.
- Transportation can be conducted via all types of covered transport while strictly maintaining the required temperature profile. Depending on specific MSDS provisions, the product falls under regulated hazard classes (requires appropriate toxic material labeling when shipped in bulk volumes).
- Shelf Life: 3–5 years from the date of manufacture (dependent on the manufacturing site and assuming the structural integrity of the original container is maintained).
Technical Specifications
Appearance
White or almost white crystalline powder, slightly hygroscopic
Assay (on dried basis)
99.0% – 101.0%
Solubility
Sparingly soluble in water, freely soluble in methanol, soluble in ethanol (96%), practically insoluble in chloroform
Appearance of Solution
The solution must be clear and not more intensely colored than the reference standard
pH (1% aqueous solution)
7.0 – 8.5
Related Substances (HPLC)
Any individual impurity: NMT 0.2%
Loss on Drying
Not more than 0.5%
Heavy Metals
Not more than 10 ppm
Supply info
- 25 kg fiber drums (or specialized pharmaceutical-grade kegs) lined with a double-layer inner polyethylene bag (standard industrial packaging).
- Custom, smaller batch packaging is available upon request for research and development (R&D) laboratories or pilot-scale manufacturing.