Introduction to Chenodeoxycholic Acid
Chenodeoxycholic acid (CDCA) is a naturally occurring bile acid in humans. It is widely used as an Active Pharmaceutical Ingredient (API) in oral formulations for the dissolution of radiolucent cholesterol gallstones and for the treatment of certain rare bile acid synthesis disorders, such as cerebrotendinous xanthomatosis (CTX). CDCA works by suppressing hepatic cholesterol and cholic acid synthesis, which gradually reduces biliary cholesterol saturation and allows gallstones to dissolve over time.
CDCA was first approved by the U.S. FDA in 1983 for gallstone dissolution and received European Medicines Agency (EMA) approval in 2017 for inborn errors of primary bile acid synthesis.
Certificate of Analysis (COA)
| Parameter | Specification | Typical Result |
|---|---|---|
| Appearance | White to off-white crystalline powder | Complies |
| Assay (on dried basis) | 98.0% – 102.0% | 99.2% |
| Identification (HPLC) | Retention time matches reference standard | Complies |
| Related Substances | Any individual impurity ≤ 0.5%; Total impurities ≤ 1.5% | 0.78% (total) |
| Loss on Drying | ≤ 1.0% | 0.6% |
| Residue on Ignition | ≤ 0.2% | 0.1% |
| Heavy Metals | ≤ 20 ppm | Complies |
| Specific Optical Rotation | +11° to +13° (c=1, CHCl₃) | +12.2° |
| Melting Point | 165–167°C | 166°C |
| Particle Size Distribution | As per customer specifications (micronized available) | D90 ≤ 180 µm |
| Residual Solvents | Meets ICH Q3C requirements | Complies |
| Microbial Limits | TAMC ≤ 1000 cfu/g; absence of specified pathogens | Complies |
Note: Batch-specific COA is available upon request.
Chenodeoxycholic Acid benefits
- Naturally occurring primary bile acid – CDCA is a physiological bile acid naturally synthesized in the human liver from cholesterol, making it a well-tolerated and biologically compatible API
- Proven gallstone dissolution therapy – CDCA was the first agent introduced in the U.S. market for the treatment of radiolucent cholesterol gallstones. Clinical studies demonstrate that adequate dosing (≥15 mg/kg/day) achieves response rates of up to 83% in selected patients
- FXR nuclear receptor activation – CDCA is the endogenous ligand for the farnesoid X receptor (FXR), a key regulator of bile acid and cholesterol metabolism. This mechanism underlies its therapeutic effects in cholesterol homeostasis
- Orphan drug designation for rare diseases – CDCA is indicated for the treatment of cerebrotendinous xanthomatosis (CTX), a rare inherited disorder of bile acid synthesis due to sterol 27-hydroxylase deficiency
- Well-established regulatory status – FDA-approved since 1983 and EMA-approved since 2017, with a documented safety and efficacy profile spanning over four decades of clinical use
- Versatile API for multiple formulations – Available as a powder for formulation into film-coated tablets (250 mg) and hard capsules, with flexible dosage options
- Bitter-tasting white powder – Consistent physical properties (white powder, crystalline and amorphous particles) support reliable manufacturing processes
What is Chenodeoxycholic Acid used for?
Pharmaceutical Applications (Human Medicine):
- Active Pharmaceutical Ingredient (API): Formulated into oral dosage forms, including film-coated tablets (250 mg) and hard capsules
- Gallstone Dissolution: Indicated for the dissolution of radiolucent cholesterol gallstones in patients with visualized gallbladders. CDCA suppresses hepatic cholesterol synthesis, gradually desaturating bile and dissolving cholesterol stones. It does not affect radiopaque (calcified) gallstones or radiolucent bile pigment stones
- Cerebrotendinous Xanthomatosis (CTX): First-line replacement therapy for inborn errors of primary bile acid synthesis due to sterol 27-hydroxylase deficiency in adults and children from 1 month of age. Oral CDCA (750 mg/day) reduces cholestanol accumulation and prevents neurological deterioration
- Bile Acid Synthesis Disorders: Treatment of congenital primary bile acid synthesis deficiencies
- Orphan Drug Indication: CDCA has orphan drug status for the treatment of CTX in the EU and other regions
Note: All applications must comply with local regulatory requirements, including applicable approvals and marketing authorizations. CDCA should be reserved for carefully selected patients and treatment must be accompanied by systematic monitoring for liver function alterations.
Frequently Asked Questions (FAQ)
Q: What is the difference between chenodeoxycholic acid and ursodeoxycholic acid?
A: Both are primary bile acids, but they differ in hydroxyl group stereochemistry. CDCA has 3α,7α-dihydroxy configuration, while UDCA has 3α,7β-dihydroxy configuration (the 7-epimer of CDCA). CDCA is primarily used for gallstone dissolution and CTX, while UDCA is more commonly used for primary biliary cholangitis.
Q: What is the solubility profile of CDCA?
A: CDCA is freely soluble in methanol, acetone, and acetic acid, but practically insoluble in water. This property should be considered during formulation development.
Q: What is the patent status of this API?
A: Chenodeoxycholic acid is off-patent in most major markets. Customers are responsible for conducting their own freedom-to-operate analysis for specific formulations.
Q: What are the key impurities to monitor?
A: Key impurities include related bile acids such as lithocholic acid and other dihydroxy bile acid isomers. Our COA provides full impurity profiles per specifications.
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How to contact
Contact our sales team to discuss your Chenodeoxycholic Acid Powder requirements.
Please get in touch with us at ella.zhang@huilinbio-tech.com.
References
[1] Chenodiol Tablets, 250 mg. DailyMed, U.S. National Library of Medicine.
[5] Chenodeoxycholic Acid. PubChem, National Center for Biotechnology Information.
Disclaimer
This product is an API/intermediate for manufacturing only, not for human consumption. Information is B2B only, not medical advice. Buyers must comply with regulations and secure approvals. CDCA requires liver function monitoring due to hepatotoxicity risks. Specifications may change; request current documentation.
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