Key Properties of Adapalene
| Product Name: | Adapalene |
| Synonyms: | 6-[3-(1-adamantyl)-4-methoxyphenyl]naphthalene-2-carboxylic acid |
| CAS No: | 106685-40-9 |
| Chemical Formula: | C₂₈H₂₈O₃ |
| Grade: | USP |
| Appearance: | White to off-white powder or crystalline solid |
| Molar Mass: | 412.52 g/mol |
| Solubility: | Sparingly soluble in THF; very slightly soluble in diethyl ether |
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BroucherManufacturing process of Adapalene
The manufacturing process begins with ensuring equipment cleanliness and availability of utilities, raw materials, and packing materials. Charge solvent such as toluene or dimethylformamide (DMF) into a glass-lined reactor (GLR). Further, gradually add 3-(1-adamantyl)-4-methoxybenzoyl chloride and 2-naphtholic acid under continuous stirring.
Heat the reaction mass up to 80–85°C and maintained at this temperature for 240–360 minutes, take the in-process sample for reaction monitoring by HPLC. After in-process result complies, cool the reaction mass at 20–25°C, and add hexane in reaction mass for crystallization, stir the the reaction mass for 100-120 minutes to promote crystal formation.
The crystallized product is then filtered using a centrifuge and washed with chilled anti-solvent to remove impurities. The wet cake is transferred to a vacuum dryer and dried at 60–65°C for 8–10 hours to achieve the desired moisture content. The dried product is milled to ensure uniform particle size and sieved through a specified mesh size.
Finally, Pack Adapalene in a clear poly bag under nitrogen blanketing 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 sealed with a heat seal machine. Finally, place the sealed aluminum bag in an HDPE container. Store Adapalene in a tightly closed, light-resistant container under nitrogen blanketing at a temperature of 2°C to 8°C.
Applications of Adapalene
Technical Specifications of Adapalene
| Sr.No. | Test | Specification |
|---|---|---|
| 1 | Description | White to off white powder |
| 2 | Solubility | Sparingly soluble in THF; very slightly soluble in diethyl ether. |
| 3 | Identification | |
| By IR | The Infrared absorption spectrum of the substance being examined must be concordant with the IR spectrum obtained from Adapalene working standard. | |
| By HPLC | In the test for assay, the retention time of principal peak from the sample should match with that from Adapalene working standard | |
| 4 | Melting range | Between 318.0°C and 326.0°C |
| 5 | Loss on drying | Not more than 0.50% w/w |
| 6 | Residual on ignition | Not more than 0.20% w/w |
| 7 | Heavy metals | Not more than 20 ppm |
| 8 | Related substances by HPLC | |
| Single maximum impurity | Not more than 0.50% | |
| Total impurities | Not more than 1.00% | |
Packing and Storage condition of Adapalene
Pack Adapalene in a clear poly bag under nitrogen blanketing 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 sealed with a heat seal machine. Finally, place the sealed aluminum bag in an HDPE container. Store Adapalene in a tightly closed, light-resistant container under nitrogen blanketing at a temperature of 2°C to 8°C.
Why Choose Chemignition for
Adapalene Supply?
Quality Assurance
Grade Compliance
Adapalene 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
Adapalene 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.
