Diclofenac diethylamine Cas 78213-16-8
Specification
Items | Specifications | Results |
Appearance | White to light beige, crystalline powder | Conforms |
Solubility | Sparingly soluble in water and in acetone,freely soluble in Methanol,Ethanol(96%);practically insoluble in 1 mol/L sodium hydroxide. | Conforms |
Identify | (1) IR-Spectrum (2) TLC chromatogram | Conforms Conforms |
Clarity and colour of solution | Clear Absorption at 440nm max 0.05 | Conforms 0.041 |
Related substances | Single impurity max 0.2%; Total impurity max 0.5% | 0.06% 0.09% |
PH value | 6.4—8.4 | 7.30 |
Loss on drying | Max 0.50% | 0.32% |
Heavy metals | Max 10ppm | Conforms |
Sulphated substances | Not more than 0.1% | Conforms |
Partical Size | 90%<200mesh | Conforms |
Assay(Titration) | 99.0%~101.0%(on dried substance) | 99.42% |
Conclusion | The product conforms to the above specifications. |
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Diclofenac diethylamine is a chemical salt form of diclofenac, a well-known nonsteroidal anti-inflammatory drug (NSAID). It is specifically designed for topical application (applied to the skin) rather than oral use.
The key difference lies in its formulation:
Diclofenac sodium or potassium (common oral forms) are designed to be absorbed into the bloodstream.
Diclofenac diethylamine is more lipophilic (fat-soluble), which allows it to penetrate the skin barrier more effectively to reach the underlying inflamed tissues (muscles, joints, tendons) with minimal absorption into the systemic circulation.
Primary Uses
It is almost exclusively used in topical medications to provide localized pain relief and reduce inflammation. Common brand names include Voltaren Emulgel, Voltaren Gel, and various generic equivalents.
Its main therapeutic uses are for acute and chronic musculoskeletal conditions, such as:
Osteoarthritis: Particularly in superficial, accessible joints like the knees, hands, and fingers.
Sprains and Strains: For example, ankle sprains or muscle strains.
Tendinitis: Such as tennis elbow (lateral epicondylitis) or golfer's elbow.
Localized Joint or Muscle Pain: From overuse, injury, or rheumatic conditions.
Back Pain: For localized pain in the lower or upper back.
How It Works (Mechanism of Action)
Like all NSAIDs, it works by inhibiting enzymes called cyclooxygenases (COX-1 and COX-2). This inhibition reduces the production of prostaglandins, which are chemicals in the body that promote inflammation, pain, and fever. By blocking them at the site of application, it decreases local inflammation and relieves pain.
Advantages of the Topical Form (Diclofenac Diethylamine)
Targeted Relief: Delivers the medication directly to the painful area.
Lower Systemic Absorption: Results in significantly lower levels of the drug in the bloodstream compared to oral diclofenac. This reduces the risk of common oral NSAID side effects, such as stomach ulcers, gastrointestinal bleeding, and potential kidney or cardiovascular issues.
Suitable for Patients: Often prescribed for older patients or those with a history of stomach problems who cannot tolerate oral NSAIDs.
Important Safety and Usage Notes
For External Use Only: Must not be applied to broken, infected, or damaged skin, or near mucous membranes (eyes, mouth).
Side Effects: Mostly local and mild, such as skin rash, itching, redness, or dryness at the application site.
Systemic Risk: While low, some absorption does occur. It should be used with caution in individuals with asthma, aspirin-sensitive patients, or those with severe kidney or heart conditions.
Dosage: Typically applied 3-4 times daily, as directed. The amount used is measured in grams (e.g., a specific length of gel from the tube).
Summary
Diclofenac diethylamine is a topical formulation of the NSAID diclofenac. Its primary use is to treat localized pain and inflammation in muscles, joints, and tendons—such as from osteoarthritis, sprains, and tendinitis—while minimizing the systemic side effects associated with oral NSAIDs. Always consult a doctor or pharmacist before use to ensure it is appropriate for your specific condition and medical history.
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Contact information
Spring Zhang
Email: export@fortunachem.com
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Tel: +86-27-59207892
Website: www.fortunachem.com