Adapalene, with a molecular formula of C28H28O3, is a white or off-white powder at room temperature and is insoluble in water or ethanol. In 2016, the U.S. Food and Drug Administration approved Adapalene as an over-the-counter acne drug that can help unclog pores and control oil. Compared with retinoic acid and isotretinoin, Adapalene has the advantages of less irritation and fewer side effects.
| Test Items | Standard | Test Results |
| Characteristics | White to off white powder | Complies |
| Identification | IR Complies | Complies |
| Solubility | Practically insoluble in water and ethanol,sparingly soluble in tetrahydrofuran | Complies |
| Solution of appearance | Solution clear Colour ≤BY6 | Complies |
| Heavy metals | ≤20ppm | Complies |
| Loss on drying | ≤0.5% | 0.09% |
| Sulphated ash | ≤0.1% | 0.07% |
| Related substances | Impurity A ≤0.3% Impurity D ≤0.2% Impurity C ≤0.15% Unknow impurity ≤0.1% Total impurities ≤0.5% | 0.03% ND ND 0.01% 0.04% |
| Residual solvent | Tetrahydrofuran ≤720ppm Acetic acid ≤5000ppm Methanol ≤3000ppm Dichloromethane ≤600ppm N,N-dimethyl formamide ≤880ppm | 490ppmNDNDNDND |
| Assay | 98.0~ 102.0% （On dried basis） | 99.8% |
| Conclusion | Complies with EP7.0 standard. | |
Adapalene is a dermatological drug. It is a substance similar to retinoic acid and has multiple pharmacological effects.
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