Pharm Ingredients
Chenodeoxycholic Acid CDCA Powder
Chenodeoxycholic Acid CDCA Powder Manufacturers & Supplier
Chenodeoxycholic acid (CDCA) is a vital bioactive bile acid with immense value in the pharmaceutical industry; it serves as a key raw material for medications treating liver diseases, gallstones, and metabolic disorders, offering broad prospects for industry growth.
Kintainutri® CDCA powder is produced from carefully selected, high-quality raw materials. The entire manufacturing process strictly adheres to Good Manufacturing Practice (GMP) standards, featuring meticulous control over every production stage to ensure consistent quality and reliable safety. The product meets rigorous international pharmaceutical standards and is suitable for the development of various pharmaceutical formulations.
Chenodeoxycholic Acid CDCA Powder Specification
| Characteristic/Method | Specification | Test Method |
|---|---|---|
| Appearance | White Crystalline Powder | URS-01/S2/STP/01 |
| Animal Source | Duck Bile | URS-01/S2/STP/01 |
| Identification |
The IR spectrum of the sample is concordant with the IR spectrum of the working/reference standard of Chenodeoxycholic acid. The retention time of the Chenodeoxycholic acid in the chromatogram of the sample solution should correspond to that in the chromatogram of the Chenodeoxycholic acid in standard solution as obtained in the test for assay by HPLC. |
URS-01/S2/STP/01 |
| Specific Optical Rotation | Between +11.0° ~ +13.0° | URS-01/S2/STP/01 |
| Loss on Drying | ≤1.0% | URS-01/S2/STP/01 |
| Sulfated Ash | ≤0.5% | URS-01/S2/STP/01 |
| Related Substances | Cholic Acid: ≤0.8% | URS-01/S2/STP/01 |
| Hyodeoxycholic acid: ≤0.4% | ||
| Unspecified impurity: ≤0.4% | ||
| Lithocholic acid content: ≤0.3% | ||
| Total Impurities | ≤1.0% | URS-01/S2/STP/01 |
| Assay | ≥98% | URS-01/S2/STP/01 |
| Conclusion | Conforming to Enterprise Standard | |
| Packaging Description | Sealed export grade drum & double of sealed plastic bag | |
| Storage | Store in cool & dry place. Keep away from strong light and heat. | |
| Shelf Life | 2 years when properly stored | |
How To Make Chenodeoxycholic Acid CDCA Powder?
Regulatory Status Of Chenodeoxycholic Acid CDCA Powder
EFSA: Chenodeoxycholic acid (CDCA) was granted orphan drug designation by the EMA for the treatment of cerebrotendinous xanthomatosis (CTX), a rare disorder caused by congenital defects in bile acid synthesis. This approval was based on more than 40 years of clinical experience and retrospective study data, with the EMA determining that its benefits outweigh the potential risks. This product is a high-purity, pharmaceutical-grade raw material intended solely for export and legitimate applications.
FDA: The FDA has approved chenodeoxycholic acid (CDCA) for the treatment of cerebrotendinous xanthomatosis (CTX), providing patients with a safe and effective therapeutic option supported by regulatory approval. However, from a safety monitoring perspective, the prescribing information for chenodeoxycholic acid includes a boxed warning regarding potential hepatotoxicity.
Chenodeoxycholic Acid CDCA Powder Benefits
Chenodiol for gallstones
Low-dose chenodeoxycholic acid (CDCA) can prevent gallstone recurrence following dissolution therapy. Its mechanism involves inhibiting hepatic cholesterol synthesis and reducing biliary cholesterol saturation, thereby promoting stone dissolution; it is most effective against small "floating" stones, with efficacy rates ranging from 15% to 90%. Notably, up to 30% of patients experience a transient rise in serum transaminases during treatment; these elevations are typically mild, asymptomatic, and dose-dependent. While some literature mentions a "black box warning" regarding hepatotoxicity, clinically apparent liver injury accompanied by jaundice is extremely rare. Kintainutri® offers high-purity, API-grade chenodeoxycholic acid powder suitable for use as an API, a pharmaceutical intermediate, and in compliance-related research.
Chenodeoxycholic acid for CTX
CDCA is currently the most effective treatment for CTX. In patients with CTX, mutations in the CYP27A1 gene lead to impaired bile acid synthesis, resulting in the abnormal accumulation of cholesterol metabolites (such as cholestanol and 23S-pentanol) in tissues like the brain and tendons, which causes progressive neurological damage. By supplementing with exogenous bile acids, CDCA inhibits CYP7A1 gene expression via negative feedback, thereby blocking the production of these abnormal metabolites at the source. The Phase III RESTORE study demonstrated that treatment with CDCA (250 mg three times daily) reduced urinary 23S-pentanol levels approximately 20-fold and plasma cholestanol levels 2.8-fold (p<0.0001).
Early intervention can significantly improve the disease trajectory, delaying or preventing irreversible neurological damage. Chenodeoxycholic acid powder is suitable for use as a pharmaceutical raw material in the treatment of CTX.
Chenodeoxycholic Acid CDCA Powder Uses
Chenodeoxycholic acid supplement
As a raw material for dietary supplements, CDCA is primarily used to support hepatobiliary health and lipid metabolism by modulating the bile acid pool composition, facilitating the absorption of fat-soluble vitamins, and maintaining cholesterol homeostasis. In the functional food and nutritional supplement sectors, chenodeoxycholic acid supplement supports hepatic metabolic function, helps maintain healthy cholesterol levels, and promotes the digestion and absorption of lipids. It is suitable for use in capsules, tablets, and complex nutritional supplement formulations, targeting consumers interested in liver health, lipid metabolism, and digestive support. Kintainutri® offers high-purity CDCA powder suitable for the development of dietary supplements and functional foods, with support for customized specifications.
Chenodeoxycholic Acid API
CDCA is a crucial starting material for the production of gallstone-dissolving agents and hepatobiliary drugs. As an FDA-approved medication for gallstone dissolution, CDCA powder promotes stone dissolution by reducing the cholesterol saturation of bile. In recent years, FDA approval of CDCA for the treatment of cerebrotendinous xanthomatosis (CTX) has further expanded the scope of its clinical application. Furthermore, CDCA serves as a key precursor for the synthesis of ursodeoxycholic acid (UDCA) and other bile acid derivatives, occupying a central position as a starting pharmaceutical raw material within the hepatobiliary drug industry chain.
CDCA as Feed Additive applications
Research in the field of aquaculture indicates that supplementing feed with 300 mg/kg of CDCA effectively improves the growth performance and liver and intestinal health of farmed fish, suggesting its potential for application in animal nutrition.
Chenodeoxycholic Acid CDCA Powder Dosage
| Population | Starting Dose | Maximum Dose |
|---|---|---|
| Adults | 750 mg/day (250 mg three times daily) | 1,000 mg/day (250 mg four times daily) |
| Paediatric (1 month – 18 years) |
5 mg/kg/day in three divided doses | 15 mg/kg/day |
|
Neonates
(< 1 month)
|
Safety and efficacy have not been established. | — |
Special populations: Data are lacking for patients with hepatic or renal impairment; individualized dose adjustment and close monitoring are required.
Chenodeoxycholic Acid CDCA Powder Side Effects
In clinical studies, the adverse reactions of CDCA were generally mild and transient. In two non-interventional studies, 63 patients reported only 3 adverse reactions, all of which were non-serious events: constipation (1 case in adults and 1 case in children) and liver adverse reactions (1 case in a 2-week-old infant). The infant also suffered from confounding factors such as parechovirus infection, combined use of drugs that affect liver function, and hyperbilirubinemia at birth. The liver function returned to normal after discontinuation of the drug, and did not recur after re-administration at a reduced dose of 5 mg/kg/day.
Overall, chenodeoxycholic acid CDCA demonstrated a favorable safety and tolerability profile; the most common adverse effects were diarrhea, headache, abdominal pain, constipation, hypertension, muscle weakness, and upper respiratory tract infections, while liver-related events were rare and largely associated with confounding factors.
Where Can I Buy Chenodeoxycholic Acid CDCA Powder?
Kintainutri® offers high-purity Chenodeoxycholic Acid (CDCA) powder (purity ≥95%), suitable for pharmaceutical API production, intermediates, and compliance-related research. Backed by rigorous manufacturing processes and quality control systems, the product ensures batch-to-batch consistency and stability, with customizable packaging options available. Please contact our technical team for specifications, impurity profiles, or stability data.
*Kintainutri® Promise All Products: Non-Irradiated / Non-ETO/ Treat by Heat Only / Non-GMO
Reference:
[1]: https://en.wikipedia.org/wiki/Chenodeoxycholic_acid
[2]: https://ec.europa.eu/health/documents/community-register/2021/20211209153743/anx_153743_en.pdf
[3]: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-cerebrotendinous-xanthomatosis-rare-lipid-storage-disease
[4]: https://www.ncbi.nlm.nih.gov/books/NBK547907/
[5]: https://pmc.ncbi.nlm.nih.gov/articles/PMC12649188/
[1]: https://en.wikipedia.org/wiki/Chenodeoxycholic_acid
[2]: https://ec.europa.eu/health/documents/community-register/2021/20211209153743/anx_153743_en.pdf
[3]: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-cerebrotendinous-xanthomatosis-rare-lipid-storage-disease
[4]: https://www.ncbi.nlm.nih.gov/books/NBK547907/
[5]: https://pmc.ncbi.nlm.nih.gov/articles/PMC12649188/
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