Tamibarotene is a synthetic retinoid and selective retinoic acid receptor (RAR) agonist, also known as AM-80 or retinobenzoic acid. It is chemically identified as 4-[(5,5,8,8-tetramethyl-6,7-dihydronaphthalen-2-yl)carbamoyl]benzoic acid. Tamibarotene has the molecular formula C22H25NO3 and a molecular weight of approximately 351.44 g/mol. Its CAS Number is 94497-51-5.
Tamibarotene is a retinoid with activity primarily associated with retinoic acid receptor alpha (RARα), and it has been developed for antineoplastic applications. It is approved in Japan for treatment of recurrent acute promyelocytic leukemia (APL).
Tamibarotene is a dicarboxylic-acid monoamide structurally related to retinoic acid receptor agonists. The molecule contains a tetralin-derived hydrophobic region connected through an amide linkage to a benzoic-acid moiety.
CAS Number: 94497-51-5
Molecular Formula: C22H25NO3
Molecular Weight: 351.44 g/mol
Synonyms: AM-80, AM80, Retinobenzoic Acid
Therapeutic Class: Synthetic Retinoid / RAR Agonist
API Type: Small-Molecule Antineoplastic API
Tamibarotene acts as an agonist of retinoic acid receptors, particularly RARα. Activation of these nuclear receptors influences transcription of genes involved in cellular differentiation and proliferation.
Its pharmacological activity has been investigated in relation to differentiation of malignant cells, particularly in acute promyelocytic leukemia. Tamibarotene was developed partly to address limitations associated with resistance to all-trans retinoic acid (ATRA).
Tamibarotene has an established pharmaceutical application in the treatment of recurrent acute promyelocytic leukemia (APL) in Japan. It is also being investigated in other oncology settings and drug-delivery approaches.
Its retinoid pharmacology and selective RAR activity make Tamibarotene an important pharmaceutical ingredient for research and development involving differentiation therapy and retinoic-acid receptor signaling.
Tamibarotene API should be evaluated using validated analytical procedures appropriate for the intended pharmaceutical specification.
Typical quality-control testing may include:
Commercial analytical material from Sigma-Aldrich is specified at ≥98% by HPLC, with a white to off-white powder appearance. This is an analytical/commercial specification and should not automatically be represented as a universal pharmacopoeial API release limit.
Swapnroop Drugs and Pharmaceuticals is an India-based pharmaceutical manufacturing organization supporting pharmaceutical customers with quality-focused API manufacturing and analytical documentation.
Tamibarotene is a specialized synthetic retinoid API requiring controlled synthesis, impurity profiling, chromatographic assay, residual-solvent control, and appropriate pharmaceutical documentation. The exact release specification should be established according to the intended market and customer requirements.
Tamibarotene API should be packed in suitable pharmaceutical-grade containers that protect the material from contamination, moisture, and environmental exposure.
The API should be stored under conditions established by validated stability data and the applicable product specification. Packaging configuration, retest period, and transportation conditions should be confirmed through the relevant quality documentation.
Documentation for Tamibarotene API may include:
Tamibarotene is a synthetic retinoid and selective RAR agonist with the molecular formula C22H25NO3 and CAS Number 94497-51-5. Its pharmaceutical activity is associated with retinoic-acid receptor signaling and cellular differentiation, with an established application in recurrent acute promyelocytic leukemia in Japan.
For pharmaceutical API manufacturing, control of identity, assay, related substances, residual solvents, elemental impurities, and stability is important. Swapnroop Drugs and Pharmaceuticals supports qualified pharmaceutical customers with quality-focused API manufacturing and documentation.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Melting Point | Approx. 205–210°C |