Isotretinoin, also known as 13-cis-retinoic acid, is a member of the retinoid class of drugs used to treat common skin conditions such as acne, rosacea, and psoriasis. Different types of retinoids have different mechanisms of action and ranges of use. The main oral retinoids used for acne treatment are isotretinoin and retinoate. Isotretinoin has a stronger effect than retinoate in suppressing oil secretion and is the preferred treatment for severe acne.
| Product Name | Isotretinoin | Standard | USP42 |
| Storage conditions | Preserve in tight containers,preferably under an atmosphere of an inert gas,protected from light. | ||
| Test | Acceptance Criteria | Result | |
| Description | Yellow or orange crystalline powder | Orange crystalline powder | |
| Identification | The IR absorption spectrum should correspondwith reference spectrum | Complies | |
| Should exhibits maximum absorption at354nm | Complies | ||
| Loss on drying | Not more than 0.5% | 0.01% | |
| Residue on ignition | Not more than 0.1% | 0.03% | |
| Heavy metals | Not more than 0.002% | Complies | |
| Limit of tretinoin | Not more than 1.0% | 0.08% | |
| Assay | 98.0%~102.0% ( Calculated on the dried basis) | 99.5% | |
It inhibits sebaceous gland activity, reducing sebum secretion, and the growth and reproduction of Propionibacterium acnes, thereby reducing epithelial cell keratinization and keratin plugging at the entrance of the sebaceous glands, thereby unclogging clogged hair follicles.
It also has anti-inflammatory and scar prevention effects.
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