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Nutraceutical & Pharmaceutical Ingredient

Tauroursodeoxycholic AcidTUDCA · CAS 14605-22-2 · High-Purity Bile Acid Ingredient

A hydrophilic bile acid formed by conjugating ursodeoxycholic acid (UDCA) with taurine. White to off-white crystalline powder; assay 98.0~102.0% on the anhydrous basis, with measured batches at 99.6-99.8%. A high-purity ingredient for dietary supplements, pharmaceutical formulations and research use.

CAS 14605-22-2 Formula C₂₆H₄₅NO₆S Standard In-house Standard Packaging 25 kg / drum

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≥98%Assay spec. minimum (HPLC)

99.8%Highest measured batch assay

≤10 ppmHeavy metals limit

6.0~7.5%Water (crystal water) range

≤0.5%Total impurities limit

200 meshParticle size: 85% through

24 monthsRetest / Shelf life

01 / Product Overview Overview

An increasingly well-studied conjugated bile acid

TUDCA is the taurine conjugate of ursodeoxycholic acid (UDCA). It occurs naturally in the human body, though only in trace amounts. Acting as a ‘chemical chaperone’, it alleviates endoplasmic reticulum stress, stabilises mitochondria and suppresses apoptotic signalling, which keeps it in focus across hepatobiliary health, metabolism and neuroprotection research.

From molecule to function. TUDCA is formed by condensing the carboxyl group of UDCA with the amino group of taurine, and is more hydrophilic than UDCA. The package insert describes its pharmacology as increasing bile acid secretion, altering bile acid composition, inhibiting hepatic cholesterol synthesis and lowering the cholesterol saturation index of bile, thereby supporting the gradual dissolution of cholesterol gallstones.

From drug to dietary supplement. As a drug, tauroursodeoxycholic acid capsules (TAUROLITE®, 250 mg) are approved in China for dissolving cholesterol gallstones. As a supplement ingredient, overseas finished products are mainly 250 mg / 500 mg capsules, with typical daily intakes of 500-1500 mg, mostly in liver and digestive health formulas.

Note: apart from the approved hepatobiliary indication, antioxidant and neuroprotective directions remain at the experimental or early clinical stage and do not constitute efficacy claims; finished-product labelling and claims must be assessed by the brand owner under the regulations of the target market.

High purity, low impuritiesAssay 98.0-102.0% (HPLC, anhydrous basis), with specified impurities such as taurine, UDCA and taurochenodeoxycholic acid controlled individually.

Fully traceable analytical methodsCP2020 methods plus GB 4789 microbiological methods; dual identification by IR and HPLC; COA issued per batch.

Powder properties suited to capsule filling85% through 200 mesh; bulk density 0.25-0.4 g/mL and tapped density 0.4-0.6 g/mL for easy blending and automated production.

Physicochemical & Developability Data

Formula	C₂₆H₄₅NO₆S（·2H₂O）
Molecular weight	499.71 (anhydrous) / 535.74 (dihydrate)
Appearance	White to off-white crystalline powder
Solubility	Freely soluble in methanol and ethanol; slightly soluble in water; insoluble in acetone
Specific rotation	+41° ~ +47°
pH (acidity)	1.3 ~ 2.3
LogP / LogD	2.20 / −0.17
TPSA / acidic pKa	123.93 / 1.98
Solubility (predicted)	26.55 mg/mL
Plasma protein binding	87.12% (human)

Sources: package insert, in-house specification sheet and the Global Drug Analysis System report (2026-01-16) AI developability predictions. Predicted values are for formulation and R&D reference only.

Nomenclature & Registry

Chinese generic name	Tauroursodeoxycholic acid / taurine ursodeoxycholic acid
English name	Tauroursodeoxycholic Acid (TUDCA)
Common synonyms	TAUROLITE, Tudcabil, Taurolite®
ATC Code	A05AA02 Bile acids and derivatives
Dosage form (drug)	Hard capsule / oral, 250 mg

02 / Specification Specifications

An in-house standard with item-by-item control

The tables below are grouped by appearance, identification, assay and related substances, residual solvents, heavy metals, microbiology and powder properties. Standards follow the in-house specification sheet and COAs; typical results are drawn from three March 2025 batches and a publicly available peer COA.

A. Appearance · Identification · Assay · Related Substances

Units: % or ppm

Item	Standard	Typical Result	Method
Appearance & Identification
Appearance	White to off-white crystalline powder	Complies	Visual
Solubility	Freely soluble in methanol/ethanol; slightly soluble in water; insoluble in acetone	Complies	CP2020
Identification A	IR spectrum conforms to reference standard	Conforms	IR
Identification B	Principal peak retention time matches reference	Conforms	HPLC
Assay & Related Substances
Assay (anhydrous basis)	98.0 ~ 102.0%（≥98%）	99.6 ~ 99.8%	HPLC
Water / Moisture	6.0-7.5% (spec sheet 6.5-7.5%)	6.9 ~ 7.0%	CP2020-04-0832
Sulphated ash	≤ 0.1%	0.05 ~ 0.06%	CP2020-04-0841
Taurine	≤ 0.15% (internal ≤ 0.1%)	< 0.02%	CP2020-04-0502
UDCA	≤ 0.5% (spec sheet ≤ 0.4%)	0.05 ~ 0.10%	CP2020-04-0502
TCDCA	≤ 0.8% (internal ≤ 0.3%)	< 0.01% / 0.30%	HPLC
Other single impurity / total impurities	≤ 0.4% / ≤ 0.5%	0.04% / 0.14%	HPLC

Note: In-house standards differ slightly between manufacturers for TCDCA and UDCA limits (0.3% / 0.8%, 0.4% / 0.5%). Both are listed here for benchmarking; the mutually agreed specification governs delivery.

B. Residual Solvents · Elemental Impurities · Microbiology · Powder

Units: % / ppm / CFU·g⁻¹

Item	Standard	Typical Result	Method
Residual Solvents & Inorganic Impurities
Triethylamine / ethanol	Each ≤ 0.5%	<0.02% / 0.02%	CP2020-04-0861
Isopropanol / acetone	Each ≤ 0.5%	<0.01%	CP2020-04-0861
Ethyl acetate (spec sheet)	≤ 0.5%	Reported per batch	GC
Chloride / sulphate	≤ 0.02% / ≤ 0.05%	Reported per batch	CP2020-04-0801
Arsenic salt	≤ 0.0002%	Reported per batch	CP2020-04-0822
Heavy Metals & Elemental Impurities
Total heavy metals	≤ 10 ppm (common industry ≤ 20 ppm)	< 10 ppm	CP2020-04-0821
Pb / As / Cd	Each < 1 ppm	Conforms	CP2020-04-0821
Hg	< 0.1 ppm (internal < 1 ppm)	Conforms	CP2020-04-0821
Microbiological Limits
Total plate count	≤ 1000 CFU/g	Conforms	GB 4789.2
Mould & yeast	≤ 100 CFU/g	Conforms	GB 4789.15
E. coli / Salmonella	Absent / 10 g	Not detected	GB 4789.3/.4
S. aureus	Absent / 10 g	Not detected	GB 4789.10
Powder Properties
Particle size	85% through 200 mesh	Customisable	CP2020-01-0100
Bulk / tapped density	0.25~0.4 / 0.4~0.6 g·mL⁻¹	Customisable	CP2020-04-0993

Note: Method codes follow the in-house specification sheet (CP2020 internal methods) and GB 4789 national standards. The methods applied are those stated in the accompanying COA and the mutually agreed quality agreement.

03 / Batch COA Data Batch COA Data

Three in-house batches + one industry benchmark

Data below are taken directly from Certificates of Analysis. Batches 830-00250301 / 0303 and TUDCA-00250301 were manufactured in March 2025 with reports issued on 11 April 2025. The peer batch is included for public specification benchmarking and does not represent the product on this page.

BATCH 830-00250301

Assay 99.8%

Batch size: 60.2 kg
Mfg. date: 2025.03.20
Report date: 2025.04.11
Valid until: 2027.03.19
Water: 6.9%
Sulphated ash: 0.05%
Total impurities: 0.14%

99.8% HPLC assay (anhydrous)

BATCH 830-00250303

Assay 99.7%

Batch size: 60.4 kg
Mfg. date: 2025.03.28
Report date: 2025.04.11
Valid until: 2027.03.27
Water: 7.0%
Sulphated ash: 0.06%
Total impurities: 0.14%

99.7% HPLC assay (anhydrous)

TUDCA-00250301

Assay 99.6%

Packaging: 25 kg / drum
Mfg. date: 2025.03.20
Report No.: TUDCAES002504001
Retest date: 2027.03.19
Water: 6.9%
Sulphated ash: 0.05%
UDCA impurity: 0.1%

99.6% English COA values

INDUSTRY REFERENCE · 20220810

Industry benchmark 99.7%

Batch size: 125 kg
Mfg. date: 2022.08.10
Test date: 2022.08.12
Valid until: 2024.08.09
Specific rotation: +45.9°
Water: 7.2%
Sulphated ash: 0.04%

99.7% Public peer COA, benchmark only

Assay by Batch

Axis range 95-101%; the vertical line marks the 98.0% specification minimum. All batches are well above the limit.

830-00250301

99.8%

830-00250303

99.7%

TUDCA-00250301

99.6%

Industry benchmark batch

99.7%

Sources: Zhejiang Hengkang Pharmaceutical CoA (Chinese / English versions) and a public peer COA; all assays by HPLC on the anhydrous basis.

04 / Applications Applications

From hepatobiliary drugs to daily nutrition formulas

Based on the package insert, supplement materials and the global R&D report, downstream uses of TUDCA fall into three areas. The descriptions below summarise literature and source materials and do not imply that this ingredient has been approved for the corresponding indications.

Dietary Supplements

Dietary Supplement Ingredient

Capsule and tablet formulas supporting liver health, normal bile flow and cellular stress relief. Overseas finished products are mainly 250 mg / 500 mg capsules, commonly combined with creatine, vitamin K2 (MK-7), vitamin D3, D-biotin, berberine and L-glutathione.

Typical formula intake: 500-1500 mg / day in divided doses
Common formats: 250 mg × 60 capsules, 500 mg × 30 capsules
Generally well tolerated; occasional mild GI effects such as diarrhoea or bloating

Supplement regulations differ from those for drugs. Dosage, contraindicated populations and label claims must be assessed by the brand owner under target-market regulations, and used under medical supervision.

Pharmaceutical / API

Pharmaceutical Formulations & API

Tauroursodeoxycholic acid capsules (TAUROLITE®) are a marketed drug at 250 mg, indicated for dissolving radiolucent cholesterol gallstones smaller than 2 cm. The package insert states a usual dose of 5-10 mg/kg/day in 2-3 divided doses after meals.

Approval No. H20110233 | Standard JX20140229
Pack: blister, 20 capsules/box | Shelf life 36 months
Originator: Bruschettini S.r.l. (Genoa, Italy)
Absorbed in the small intestine; high hepatic first-pass effect; enterohepatic circulation

The above is public package-insert information shown only to illustrate downstream use. Suitability of this ingredient for registration or filings must be assessed by the customer.

Research & Pipeline

Research & Drug Discovery

A GPBAR1 (TGR5) agonist that acts as a chemical chaperone to reduce endoplasmic reticulum stress. Beyond the approved liver and gallstone indications, the ALS direction has reached Phase III in several EU countries; metabolic and neurodegenerative directions have extensive preclinical literature.

ALS Phase III: EUCTR2018-002722-22 (NL / GB / DE, etc.)
Science (2006, Harvard): ER stress in a type 2 diabetes mouse model
63 global patents, 10 pipeline drugs, 11 companies

Investigational indications are not approved; these statements are excerpts of public R&D progress and do not constitute efficacy or indication claims.

05 / Regulatory & Development Regulatory & R&D Progress

A molecule with two decades on the market

Timeline compiled from the Global Drug Analysis System drug report (2026-01-16), covering registration filings, marketing approvals and ongoing clinical trials.

2000.01.01

First China registration filing

Acceptance No. A19990115, hard capsule for oral use; originator Bruschettini S.r.l. (Italy), with Quanfu Development Co., Ltd. as another applicant.

2006.07.25

First approval in China / worldwide

Approval No. HJ20150398, indication: cholelithiasis, 250 mg; liver-related indications also approved in Italy and the EU in the same period.

2008.08.22

First China clinical trial application

Acceptance No. JXHL0800270, hard capsule for oral use; an additional registration filing JXHS1300103 was recorded in 2013.

From Jan 2019

ALS indication enters Phase III

The EUCTR2018-002722-22 trial series advanced across the EU, France, Italy, Germany, Belgium, the UK, Ireland and the Netherlands.

2025.10.27

China approval information updated

Latest update recorded in the drug report; the highest global development stage remains ‘Marketed’.

2026.01.16

Global R&D Snapshot

Report statistics: 63 patents, 3 indications (2 approved / 1 in development), 8 clinical records, 1 translational medicine record; ranked 1/11 in the field.

A05AA02ATC: Bile acids and derivatives

GPBAR1Target: GPBAR1 agonist

63Global published patents

Phase IIIHighest global ALS development stage

06 / Market & Process Market Insights & Synthetic Route

Where demand comes from, how the molecule is made

The market section is based on global import customs records containing ‘TUDCA’ from 2024-01-01 to 2026-01-16; the process section is based on published synthetic routes and upstream UDCA test data.

Global Trade & Product Forms

Customs records show that TUDCA-containing shipments are primarily exported from China and imported overseas, with the United States as the main destination, followed by Ecuador, Russia, Uzbekistan and India. Descriptions include both ingredient-grade names and a large number of finished capsule products, indicating a mature supplement supply chain.

USA · Main destinationNUTRICOST 250 mg / 500 mg capsulesCreatine blendsVitamin K2 (MK-7)Vitamin D3D-BiotinBerberine HClAlpha-lipoic acidL-GlutathioneFibre drums / blended formulas

70+import records (sample)

2024.01–2026.01Data period

250 / 500 mgMainstream finished capsule strengths

Note: customs records cover mixed goods and finished products ‘containing TUDCA’ and do not equal export tonnage of TUDCA ingredient; they are used only to infer product forms and regional flows.

Synthetic Route & Upstream Raw Material

The mainstream route condenses ursodeoxycholic acid (UDCA, CAS 128-13-2) with taurine (CAS 107-35-7); published literature also describes microbial hydroxylation routes.

Carboxyl activationEthyl chloroformate / triethylamine forms a mixed anhydride; pivaloyl chloride or benzoyl chloride activation and active phenyl esters are also used.

↓

Coupling with taurineCondensation with taurine triethylamine salt; direct coupling with IIDQ, DEPC or EEDQ under microwave conditions is also reported.

↓

Purification & crystallisationTUDCA dihydrate is obtained, then packaged after control of water, related substances and residual solvents.

Upstream UDCA test data (EP 11.0)

Batch 20250308 / 600 kg: assay 100.1% (spec 99.0-101.0%), specific rotation +60.3° (+58° to +62°), melting point 203.1 ℃ (200-204 °C), loss on drying 0.40%, sulphated ash 0.06%, impurity A 0.39%, total impurities 0.60%; complies with EP 11.0.

07 / Packaging & Supply Packaging, Storage & Documents

Traceable, batch-wise delivery

Compiled from packaging, storage and retest information in COAs and the package insert; the mutually agreed order and quality agreement govern.

Packaging & Storage

Standard pack: 25 kg / fibre drum with moisture-barrier liner
Example batch sizes: 600 kg (March 2025 batches)
Storage: Protect from light; keep tightly closed and dry at ≤ 30 °C
Retest period: 24 months (example batches to Mar 2027)
Upstream reference: UDCA 600 kg / batch, complies with EP 11.0
Handling: Keep dry, avoid heavy stacking and co-loading with odorous goods

Technical documents available

COACertificates of Analysis (Chinese / English)Batches 830-00250301, 830-00250303, TUDCA-00250301Available

SPECIn-house specification sheet (with method codes)CP2020 / GB 4789 series / HPLCAvailable

PDFPackage insert & Reference

MSDSSDS / transport classification / quality agreementSupplied to customer compliance requirementsOn request

08 / FAQ FAQ

Common questions before sourcing

What is the difference between TUDCA and UDCA?

TUDCA is the conjugate of UDCA with taurine; the taurine group (with a sulfonic acid moiety) makes it more hydrophilic. It is produced by condensing UDCA (CAS 128-13-2) with taurine (CAS 107-35-7), so UDCA is both the upstream raw material and a specified impurity controlled in the COA (limit ≤ 0.5%; measured 0.05-0.10%).

Is 6-7.5% water content high? Does it affect the assay?

No – it is not incomplete drying. TUDCA commonly occurs as a dihydrate (formula C₂₆H₄₅NO₆S·2H₂O, MW 535.74); the theoretical water content of the crystal water is about 6.7%, consistent with the 6.0-7.5% specification. The in-house assay is expressed on the anhydrous basis (98.0-102.0%), so water and assay must be read together.

Why are both ≥98% and 98.0-102.0% used for the assay?

They come from different versions of the in-house specification sheet and COA: the spec sheet usually states ‘≥98%’, while the CoA follows pharmacopoeial convention with ‘98.0-102.0%’ (anhydrous basis). Measured batches on this page fall in 99.6-99.8% and satisfy both conventions. The mutually agreed specification governs delivery.

Can you provide samples, custom particle size or small trial batches?

Yes. Standard pack is 25 kg/drum, with 85% through 200 mesh, bulk density 0.25-0.4 g/mL and tapped density 0.4-0.6 g/mL. For a specific particle size distribution, bulk density or alternative pack size, please state the target dosage form (capsule / tablet / powder) and filling method in your enquiry and we will evaluate it.

Can this ingredient be used directly in supplement or drug filings?

This is a B2B ingredient information page. The regulatory and R&D progress shown here is compiled from public sources and does not mean this ingredient has obtained any registration, filing or indication approval. Market access requirements for bile acid ingredients vary considerably; the filing pathway and required dossiers (e.g. DMF/CTD, stability, toxicology) must be assessed by the customer under target-market regulations. We can supply supporting technical documents.

Can the efficacy descriptions on this page be printed on product labels?

We do not recommend quoting them directly. Apart from the approved hepatobiliary indication, antioxidant, cytoprotective and neuroprotective directions derive mostly from experimental or early clinical research and are descriptions of scientific progress. Finished-product labels and claims must be independently assessed by the brand owner under the regulations of the market of sale (including China health-food / novel food ingredient rules, US DSHEA and EU Novel Food).

Need a TUDCA sample, specification sheet or batch COA?

Our technical and commercial teams can support formulation, regulatory documentation advice and custom specification assessment. Urgent enquiries are answered within 4 working hours.

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