Tauroursodeoxycholic Acid, commonly known as TUDCA or Taurursodiol, is a taurine-conjugated bile acid and naturally occurring bile acid derivative. It is chemically classified as a taurinated bile acid and is studied for its effects on cellular stress pathways, mitochondrial function, bile-acid metabolism and apoptosis. KEGG identifies Tauroursodeoxycholic Acid as Taurursodiol and lists its molecular formula as C26H45NO6S with a molecular weight of 499.71 g/mol.
Tauroursodeoxycholic Acid is the taurine conjugate of ursodeoxycholic acid. It contains a steroidal bile-acid structure conjugated with taurine through an amide linkage.
The API is identified by CAS No. 14605-22-2, molecular formula C26H45NO6S, and molecular weight 499.71 g/mol.
TUDCA has been investigated in pharmaceutical and biomedical research involving cellular stress, mitochondrial dysfunction, apoptosis and neurodegenerative conditions. In the United States, taurursodiol has also been evaluated as a component of a fixed-dose combination with sodium phenylbutyrate for ALS.
| Parameter | Details |
|---|---|
| Product Name | Tauroursodeoxycholic Acid |
| Synonyms | TUDCA; Taurursodiol; Ursodoxicoltaurine |
| CAS Number | 14605-22-2 |
| Molecular Formula | C26H45NO6S |
| Molecular Weight | 499.71 g/mol |
| API Type | Small-Molecule API |
| Chemical Class | Taurinated Bile Acid |
| Therapeutic/Research Class | Bile Acid Derivative |
| PubChem CID | 9848818 |
| ChEBI ID | CHEBI:80774 |
| Primary Form | Tauroursodeoxycholic Acid |
| Sodium Salt | Sodium Tauroursodeoxycholate — CAS 14605-22-2 is also used commercially for the sodium salt in some catalogues; confirm the exact form before procurement |
The molecular identity and classification are supported by KEGG, Exposome-Explorer and chemical reference data.
Tauroursodeoxycholic Acid is investigated for applications associated with:
The FDA's review of AMX0035 describes TUDCA as one component of the sodium phenylbutyrate/tauroursodeoxycholic acid combination investigated for amyotrophic lateral sclerosis.
Quality evaluation of Tauroursodeoxycholic Acid should be based on the applicable API specification and validated analytical procedures. Depending on the intended pharmaceutical application, testing can include:
The exact numerical acceptance criteria should be taken from the applicable customer, regulatory or approved manufacturing specification rather than using generic limits.
Swapnroop supports pharmaceutical API requirements with controlled analytical testing, documentation and quality-focused manufacturing/supply capabilities. Tauroursodeoxycholic Acid can be supported with product specifications and relevant quality documentation according to the intended pharmaceutical or research application.
Tauroursodeoxycholic Acid should be packed in suitable, well-closed pharmaceutical-grade containers that protect the material from moisture, contamination and unsuitable environmental exposure.
Recommended storage conditions should follow the approved product specification and stability data for the specific batch and material form.
Depending on the application and customer requirements, documentation may include:
Swapnroop focuses on quality-oriented pharmaceutical API solutions supported by analytical testing and appropriate technical documentation. Tauroursodeoxycholic Acid can be supplied according to agreed specifications and intended application requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.5–101.5% |
| Loss on Drying | NMT 7.5% |
| Residue on Ignition | NMT 0.10% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 1.3–2.3 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | 6.5–7.5% |
| Specific Rotation | +41.0° to +47.0° |
| Melting Point | 142–146°C |