Key Properties of Diacerein
| Product Name: | Diacerein |
| Synonyms: | 4,5-bis(acetyloxy)-9,10-dioxo-9,10-dihydroanthracene-2-carboxylic acid |
| CAS No: | 13739-02-01 |
| Chemical Formula: | C19H12O8 |
| Grade: | BP/EP |
| Appearance: | Crystalline powder |
| Molar Mass: | 368.29 g/mol |
| Solubility: | Slightly soluble in water, soluble in ethanol and dimethyl sulfoxide (DMSO). |
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BroucherManufacturing process of Diacerein
The process begins with ensuring equipment cleanliness, utility availability, and confirmation of required materials.
Charge the Ethanol into the glass line reactor (GLR) and anthraquinone derivatives along with other reactants are added under stirring. Heat the reaction mass up to 80–85°C. Maintain the reaction mass at 80–85°C for 360–480 minutes.
Take the in-process sample from reactor and send the in-process sample to quality control (QC) for reaction monitoring by HPLC. After In-process result complies, cool the reaction mass to 20–25°C and add anti-solvent like water for initiate crystallization. Stirring continues at 20–25°C for 120–180 minutes to allow complete crystal formation. The crystallized product is filtered and washed with chilled solvent to remove impurities.
The wet product is dried in a vacuum dryer at 40–50°C for 480–600 minutes, then milled and sieved to achieve a uniform particle size.
Pack Diacerein in a clear poly bag and twist the mouth of the bag. Secure it with a PVC strip. Place this bag inside another poly bag, twist its mouth, and secure it with a PVC strip. Insert these bags into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Diacerein in a tightly closed, light-resistant container at a temperature below 30°C.
Applications of Diacerein
Technical Specifications of Diacerein
| Sr.No. | Test | Specification |
|---|---|---|
| 1 | Description | Yellow crystalline powder |
| 2 | Solubility | Practically insoluble in water; soluble in dimethyl sulfoxide (DMSO) |
| 3 | Identification by IR | The IR spectrum of the sample should be concordant with the reference standard |
| 4 | Melting Point | 230°C to 232°C |
| 5 | Loss on Drying | Not more than 0.5% |
| 6 | Residue on Ignition | Not more than 0.1% |
| 7 | Assay by HPLC | 98.0% to 102.0% (on anhydrous basis) |
| 8 | Related Substances by HPLC | Known Impurities: – Impurity A (1,3,8-Trihydroxy-6-methylanthraquinone): Not more than 0.5% – Impurity B (Aloe-emodin): Not more than 0.5% – Impurity C (Rhein): Not more than 0.5% – Impurity D (5-Acetyl Rhein): Not more than 0.5% – Impurity E (Monoacetyl Rhein Isomer B): Not more than 0.5% Any Other Individual Impurity: Not more than 0.1% Total Impurities: Not more than 1.0% |
| 9 | Residual Solvents by GC | – Acetone: Not more than 5000 ppm – Methanol: Not more than 3000 ppm – Dichloromethane: Not more than 600 ppm |
Packing and Storage condition of Diacerein
Pack Diacerein in a clear poly bag and twist the mouth of the bag. Secure it with a PVC strip. Place this bag inside another poly bag, twist its mouth, and secure it with a PVC strip. Insert these bags into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Diacerein in a tightly closed, light-resistant container at a temperature below 30°C.
Why Choose Chemignition for
Diacerein Supply?
Quality Assurance
Grade Compliance
Diacerein is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.
Large-Scale Manufacturing and Export
Grade Compliance
Diacerein is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.
