Isotretinoin (13-cis-Retinoic Acid) CAS 4759-48-2

FAQ - Technical & Supply Chain

• Q:

  Is Isotretinoin the same as Tretinoin?

  A: No. Isotretinoin is 13-cis-retinoic acid, CAS 4759-48-2, while tretinoin is all-trans-retinoic acid and has a different CAS, commonly cited as 302-79-4. The two substances have different isomeric configurations and cannot be substituted without confirming the relevant monograph or dossier.
• Q:

  Where is Isotretinoin used?

  A: Isotretinoin is supplied as a pharmaceutical or cosmetic active raw material for regulated finished formulations. It is not a finished drug or consumer product, so the compendial or registration reference and intended dosage form must be confirmed.
• Q:

  Which specifications should be agreed for Isotretinoin?

  A: Confirm assay and method, appearance, melting range, water, related substances including tretinoin and other retinoic acid isomers or degradation products, residual solvents, heavy metals or elemental impurities, and the applicable pharmacopoeia or dossier.
• Q:

  What are the key identity and physical properties of Isotretinoin?

  A: Isotretinoin has CAS 4759-48-2, formula C20H28O2 and molecular weight about 300.44 g/mol. It is normally a yellow-orange to orange crystalline solid with a typical melting range around 172-175 C, is practically insoluble in water, and is soluble in methylene chloride with limited solubility in ethanol.
• Q:

  How should Isotretinoin be stored and packed?

  A: Store it in tightly closed, light-protective and moisture-protective packaging under cool conditions, using inert gas where required. Isotretinoin is sensitive to air, light and heat, especially in solution, so confirm container material, seals and shipping temperature before use.