Key Properties of Adapalene API
| 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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Manufacturing process of Adapalene API
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 API
Technical Specifications of Adapalene API
| 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 API
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 API Supply?
Quality Assurance
Grade Compliance
Adapalene API 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 API 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.
