What Is Diclofenac Sodium Powder?
Diclofenac Sodium Powder(CAS:15307-79-6) is the sodium salt of diclofenac, a well-known non-steroidal anti-inflammatory drug (NSAID). It is widely used in pharmaceutical formulations for its anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) effects.
In its raw material form, Diclofenac Sodium Powder appears as a white to slightly yellowish crystalline powder and is commonly supplied as an active pharmaceutical ingredient (API) for drug manufacturing and research purposes.
Chemical & Physical Information
| Chemical name | Sodium [2-(2,6-dichloroanilino)phenyl]acetate |
| Molecular formula | C₁₄H₁₀Cl₂NNaO₂ |
| Molecular weight | ~318.13 g/mol |
| CAS number | 15307-79-6 |
| Appearance | White or off-white crystalline powder |
| Solubility | Freely soluble in water; soluble in methanol; slightly soluble in ethanol |
| pH (aqueous solution) | Typically 7.0–8.5 |
| Stability | Stable under recommended storage conditions; sensitive to strong light and moisture |
Certificate of Analysis
Product Specifications
|
Parameter |
Specification / Requirement |
|
Assay (Content) |
98.5% - 101.0% (on dried basis, as per USP/EP/ChP) |
|
Identification |
Conforms (by IR spectroscopy, UV-Vis, HPLC retention time comparison) |
|
Loss on Drying |
≤ 0.5% (crucial due to hygroscopicity) |
|
Residue on Ignition |
16.0% - 17.5% (corresponding to sodium content) |
|
Heavy Metals |
≤ 20 ppm |
|
Related Substances |
Strictly controlled via HPLC. Limits for individual impurities (e.g., dichloroaniline, chlorinated analogs) and total impurities are specified. |
|
Chloride Content |
Within limits (as a test for residual HCl from synthesis). |
|
Sodium Ions |
Confirmed by flame test or other method. |
|
Shelf Life |
Typically 36 months when stored in original, tightly sealed, moisture-proof containers. |
|
Storage |
Preserve in well-closed, light-resistant containers, in a dry place at controlled room temperature. Desiccants are often used in packaging. |
Pharmacological Profile & Mechanism of Action
Primary Mechanism: Diclofenac is a potent, non-selective inhibitor of the cyclooxygenase (COX) enzymes, COX-1 and COX-2. This inhibition blocks the conversion of arachidonic acid to prostaglandins (PGs) and thromboxanes, key mediators of inflammation, pain, and fever.
Potency: It is one of the most potent traditional NSAIDs in terms of COX inhibition in vitro.
Additional Proposed Mechanisms: May also influence arachidonic acid release and uptake, and have some effects on lipoxygenase pathways, contributing to its strong anti-inflammatory profile.
Pharmacokinetics: Rapidly absorbed, with extensive protein binding (>99%). It undergoes significant first-pass metabolism, leading to a systemic bioavailability of about 50-60%. Its half-life is relatively short (1-2 hours), but its clinical effects last longer due to persistence in synovial fluid and tissues.
Pharmaceutical Applications
Diclofenac sodium powder is widely used to manufacture various dosage forms, including:
Oral Preparations
Tablets (immediate-release, enteric-coated)
Capsules
Sachets and granules
Topical Preparations
Gels
Creams
Sprays and patches for localized pain relief
Parenteral & Other Forms
Injections
Suppositories
Ophthalmic solutions (eye drops)
Handling & Storage
Store in a cool, dry place, protected from light and moisture
Double-layer pharmaceutical-grade bags or fiber drums
Use appropriate PPE (gloves, mask, goggles) to avoid dust inhalation and skin contact
TNJONE Products are designed for research and industrial use only. Not intended for clinical or medical purposes.
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