Isotretinoin is a synthetic retinoid and stereoisomer of tretinoin (all-trans-retinoic acid). It belongs to the retinoid class of compounds and is widely used as an active pharmaceutical ingredient in dermatological preparations, particularly for the treatment of severe acne that has not responded adequately to conventional therapies.
Isotretinoin is chemically known as 13-cis-retinoic acid and is structurally related to vitamin A. It acts through retinoid-dependent pathways and produces significant effects on sebaceous gland activity, follicular keratinization, inflammation and sebum production.
Isotretinoin is identified by CAS Number 4759-48-2 and has the molecular formula C20H28O2. Its molecular weight is approximately 300.44 g/mol. It is a lipophilic, unsaturated carboxylic acid containing a conjugated polyene chain.
Isotretinoin is generally described as a yellow to orange crystalline powder. Because of its highly conjugated structure, the compound can be sensitive to light, oxygen and other environmental conditions. Appropriate pharmaceutical storage and handling conditions are therefore important for maintaining product quality.
Isotretinoin is a retinoid related to naturally occurring vitamin A derivatives. Its therapeutic activity in acne is associated with reduction in sebaceous gland size and sebum production, normalization of follicular keratinization and reduction of inflammatory processes. Isotretinoin is converted to several biologically active retinoid metabolites, including tretinoin, which participate in retinoid receptor-mediated cellular signaling.
Isotretinoin is primarily used in pharmaceutical products for the treatment of severe recalcitrant nodular acne. It may also be investigated or used in other dermatological and oncology-related applications under appropriate medical and regulatory supervision.
Pharmaceutical Isotretinoin can be characterized using validated chromatographic and spectroscopic analytical techniques. HPLC is commonly used for assay and related-substance determination, while suitable spectroscopic and chromatographic methods may be used to confirm identity.
Quality control of Isotretinoin API should include identity, assay, related substances, stereochemical or isomeric purity where applicable, water content, residual solvents and other parameters specified in the applicable pharmaceutical specification.
Isotretinoin should be stored in a tightly closed container under controlled pharmaceutical storage conditions. The material should be protected from light, excessive heat, moisture and oxidation. Specific storage conditions should follow the applicable manufacturer specification and Certificate of Analysis.
Isotretinoin API may be supplied for pharmaceutical manufacturing, formulation development, analytical testing and other qualified pharmaceutical applications. Product specifications, Certificate of Analysis, packaging configuration and regulatory documentation should be confirmed according to the intended application.
For Isotretinoin API requirements, customers can request product specifications, analytical documentation, Certificate of Analysis, packaging information and commercial details. Quality parameters should be evaluated against the applicable pharmaceutical specification before procurement.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 1.0% |