Product Introduction
TUDCA is a 99% assay-grade bile acid derivative supplied as a white crystalline powder, produced under GMP-controlled conditions for use in laboratory research, API development, and formulation manufacturing of liver-targeted products.
Application Scenarios
Used in liver disease research laboratories to evaluate hepatocyte stress response and bile acid metabolism stability under controlled experimental conditions.
Used in NAFLD and metabolic disease model development, supporting lipid accumulation and liver injury simulation in preclinical studies.
Used in pharmaceutical API screening programs, for evaluating bile acid derivative stability and compound selection in early drug pipelines.
Used in nutraceutical OEM factories, as a raw material for liver support capsule and tablet formulation production lines.
Used in CRO/CDMO projects, for ER stress and apoptosis pathway validation in biochemical research workflows.
Product Specification
|
Item |
Specification |
|
CAS Number |
14605-22-2 |
|
Molecular Formula |
C26H45NO6S·2H2O |
|
Molecular Weight |
499.70 g/mol |
|
Appearance |
White crystalline powder |
|
Assay (HPLC) |
99% |
|
Water Content |
6.0% – 8.0% |
|
Sulphate Ash |
≤0.1% |
|
Optical Rotation |
+45.0° to +47.0° |
|
Storage |
Sealed, dry, protected from light |
Quality Control System
Each batch is released only after passing a multi-stage QC system:
- Raw material verification: HPLC fingerprint matching against reference standard before production release.
- In-process control: Reaction intermediates sampled at fixed synthesis stages to confirm conversion completeness.
- Final assay control: HPLC quantitative analysis to maintain 99% ±1% assay consistency.
- Impurity profiling: LC-MS screening to control unidentified impurities within ≤0.5%.
- Physicochemical stability tests: Moisture, ash content, and optical rotation checked for batch consistency.
- Release system: Only batches passing full QC + COA review + batch traceability audit are released for shipment.
Each batch is traceable by unique production lot number linked to full analytical record.
Manufacturing & Compliance Background
GMP-compliant production facility with controlled synthesis environment
- ISO 9001:2015 certified quality management system
- 200L–5000L industrial reactor production lines
- Fixed parameter synthesis process for batch reproducibility
- Full raw material-to-finished product traceability system
- Stable supply capability from kilogram level to ton-scale orders
Optional compliance alignment: ICH Q7 / internal pharmaceutical-grade manufacturing standards
Customization Options
We support structured customization for industrial buyers:
- Purity grades: 98% / 99% / ≥99.5% pharmaceutical-grade upgrade
- Particle specifications: Standard crystalline / micronized / formulation-ready powder
- Packaging formats: 1kg / 5kg / 10kg / 25kg bulk industrial packaging
- Supply form: Single active ingredient / OEM pre-mixed formulation supply
- Labeling options: Neutral export label / private label / anti-counterfeit traceable labeling
- Documentation package: COA / MSDS / HPLC report / stability data / regulatory support file
Packaging & Logistics
Product is packed in vacuum-sealed aluminum foil inner bags or HDPE drums, then placed into moisture-proof, impact-resistant export cartons with palletized reinforcement (20–25kg standard carton loading); global shipment is available via DHL, FedEx, air freight consolidation, or sea freight container shipping with anti-moisture and anti-damage protection systems.
Documentation Support
Each shipment can be supported with:
- Certificate of Analysis (COA) per batch
- Material Safety Data Sheet (MSDS)
- HPLC chromatogram report
- LC-MS impurity profile report
- Full batch traceability record
Export compliance documentation for customs clearance
Order Information
Minimum Order Quantity: 1kg
Sample Availability: Available for pre-shipment evaluation
Lead Time: 1–3 days (stock) / 7–15 days (production batches)
Supply Models: Spot purchase / long-term contract / OEM supply agreement
FAQ
Q: How is batch consistency controlled across production runs?
A: Consistency is ensured through fixed synthesis parameters combined with HPLC and LC-MS verification for every production batch.
Q: Can third-party inspection be arranged before shipment?
A: Yes, SGS or equivalent third-party inspection can be scheduled before final dispatch.
Q: What documents are required for import clearance?
A: COA, MSDS, and export compliance documents are provided for customs clearance support.
Q: Do you support long-term supply agreements?
A: Yes, we offer stable monthly or quarterly supply contracts for bulk buyers.
Q: Can packaging be adjusted for different regulatory markets?
A: Yes, packaging and labeling can be customized for EU, US, and Asia compliance requirements.
Q: Do you provide regulatory documentation support for formulation development?
A: Yes, full technical and regulatory document packages are available for OEM and CDMO projects.
Q: Is express shipping available for urgent orders?
A: Yes, DHL and FedEx express air shipping options are available for urgent deliveries.
Q: Can I request a sample before placing a bulk order?
A: Yes, small samples are available for laboratory and formulation testing before bulk purchase.
Q: What ensures your product meets industrial research requirements?
A: Each batch is validated through HPLC assay, LC-MS impurity control, and COA release system under GMP conditions.
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