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Ursodeoxycholic Acid Powder

Ursodeoxycholic Acid Powder

Appearance:White or off-white powder
Assay:>99%
Testing Method:HPLC
Two Factories & Three production lines
GMP standard workshop & two independent laboratories
FDA Cert.
Certifications: Halal,ISO9001,PAHS Free,NON-GMO,KOSHER,SC
Overseas warehouse(NJ,USA)
Delivery term: DHL, FEDEX, Air freight,Sea freight
Provide Free Sample
MOQ: 1KG
Not for Private Person Sale

Description

Ursodeoxycholic Acid Powder Supplier:

Guanjie Biotech is a ursodeoxycholic acid supplier, providing high-quality ursodeoxycholic acid powder for pharmaceutical, nutraceutical, and healthcare applications. Our ursodeoxycholic acid UDCA powder is white with an assay of more than 99%. Each batch is tested by HPLC to verify quality and compliance with specifications. With professional production capabilities and reliable supply services, Guanjie Biotech supports global customers with premium ursodeoxycholic acid raw materials for various formulations and product development needs.

UDCA powder

What is Ursodeoxycholic acid powder?

Ursodeoxycholic acid powder is a white powder, odorless. It is soluble in ethanol, insoluble in trichloromethane. Soluble in glacial acetic acid, soluble in sodium hydroxide solution. This product is 3α,7β-dihydroxy-5β-cholestane-24-acid. It contains not less than 98.5% of C24H40O4 according to the dry product.

 

COA:

Items

Specification

Results

Appearance

White or off-white powder

White powder

Identification IR

Complies with reference

Complies

Solubility

Insoluble in water,insoluble in methylene chloride,freely soluble in ethanol,slightly soluble in acetone

Complies

Loss on drying

≤1.0%

0.36%

Melting Point

200°C~204°C

200.2°C~201.0°C

Heavy Metal

≤20ppm

Complies

Specific Optical Rotation

+58.0°~+62.0°

+58.7°

Lithocholic acid

≤0.1%

Comlies

Chenodeoxycholic acid

≤1.0%

0.04%

Single Impurity

≤0.1%

0.07%

Total Impurities

≤1.5%

0.21%

Assay

99.0%~101.0%

100.0%

Residual Solvent

 

 

Acetone

≤0.5%

0.11%

Ethyl Acetate

≤0.5%

Not detected

Isopropanol

≤0.5%

Not detected

Conclusion

We certify that the quality of this product conforms with EP9.0

 

 

 

What Is the History of Ursodeoxycholic Acid Powder?

● Ursodeoxycholic acid powder has long been used as a liver disease treatment in human medicine, and on July 26, 2004, the U.S. Food and Drug Administration (FDA) approved Ursodeoxycholic acid tablets for the treatment of primary biliary cirrhosis. This drug is currently the only drug approved by the FDA for the treatment of primary biliary cirrhosis. Decades of clinical studies have shown that ursodeoxycholic acid is a real handful in the treatment of cirrhosis. Incidentally, it also has the benefits of lowering blood lipids and promoting fat oxidation and energy supply.

 

● Since it's a liver drug, it must be going after something in the liver. As we all know, liver fibrosis is a serious medical problem. It can progress to end-stage cirrhosis or even liver death. And liver regenerative capacity is an important indicator of liver health. It is important in resisting fibrosis. Ursodeoxycholic acid has been demonstrated to promote liver regeneration through activation of the ID1-WNT2/Hepatocyte Growth Factor pathway (right picture picture if you can't understand it), thereby reducing liver fibrosis. Other studies have also demonstrated that Ursodeoxycholic acid is also useful in the treatment of drug-induced liver injury.

 

What Is Ursodeoxycholic Acid Powder Good For?

• It lowers cholesterol levels through a mechanism called negative feedback regulation.

Ursodeoxycholic acid analogue may produce efficacy against polymorphic cholesterol in gallbladder polyps through several pathways. It may alter the solubility of cholesterol in bile so that cholesterol in bile is less likely to precipitate to form crystals and polyps. And it may also reduce the deposition of cholesterol in the gallbladder mucosa by regulating the absorption and secretion functions of the gallbladder mucosa, which in turn inhibits the growth of gallbladder polyps. In addition, it might also have some anti-inflammatory effects. It can reduce the inflammatory reaction of the gallbladder mucosa. Therefore, it plays a role in hindering the development of polymorphic cholesterol in gallbladder polyps.

 

● Changing bile acid components.

There are hydrophilic and hydrophobic bile acids. Our ursodeoxycholic acid powder is hydrophilic. The ursodeoxycholic acid and deoxycholic acid that you have heard so much about are hydrophobic. Hydrophilic and hydrophobic are neither good nor bad, they are both needed by the body. But in general, because hydrophilic is easy to transport and other properties. If they are both in excess, then the hydrophobic ones are more toxic. Ursodeoxycholic acid favors bile secretion by some unknown exact mechanism, thus improving cholestasis.

 

● Lipid lowering.

Both people and fish are now talking about lipids. UDCA Powder has been shown to promote beta oxidation of free fatty acids in the liver of obese rats. It has also been shown to have therapeutic effects on non-alcoholic fatty liver.

 

● Immune modulation.

Glucocorticoids combined with ursodeoxycholic acid are effective in treating a condition called autoimmune hepatitis. A piece of the rat's liver is clicked off. It was then given ursodeoxycholic acid orally. The ursodeoxycholic acid powder was found to alter the liver's ability to regenerate by altering immune activity.

 

● Fighting the New Crown

On December 5, 2022, the journal Nature published the results of a study from the University of Cambridge in England. The main point was to determine the function of the FXR receptor in controlling the expression of angiotensin-converting enzyme 2 (ACE2, on which the Neocoronavirus relies to enter human cells). Incidentally ursodeoxycholic acid may reduce neocoronavirus infection by modulating this pathway.

 

● Other Roles

Including anti-cholestone, cardiovascular protection, anti-inflammatory, etc., may all be extensions of the above actions. Don't ask, ask is all sorts of signaling pathways.

 

 

What Is Ursodeoxycholic Acid Powder Used For? 

● Treatment of steroidal gallbladder stones.

Ursodeoxycholic acid can reduce the saturation of cholesterol in bile, and lipids restore the microgelatinous state. Thus, the cholesterol in the stones is dissolved and dislodged. It also limits the activity of hydroxy-methylglutaryl coenzyme. This reduces cholesterol synthesis and secretion to prevent and dissolve cholesterol stones. It is also useful for mixed stones.

 

● Cholestatic liver disease.

Cholestatic liver disease is associated with the accumulation of goose deoxycholic acid, deoxycholic acid, and dehydrocholic acid. These bile acids cause hepatocellular damage due to descaling. Ursodeoxycholic acid powder is a nontoxic hydrophilic bile acid that competitively inhibits the absorption of toxic endogenous bile acids in the ileum. By activating a signaling network consisting of calcium ions, protein kinase C. And by activating split-activated protein kinase to enhance the secretory capacity of cholestatic hepatocytes. This results in a decrease in the concentration of endogenous hydrophobic bile acids in the blood and hepatocytes and achieves an anticholestatic effect.

 

Kinetics

Bulk ursodeoxycholic acid powder is a weak acid. When microglial aggregation occurs, the pKa is about 6.0. After oral administration, it is mainly absorbed from the ileum. It is taken up by the liver at 5% to 60%, significantly lower than that of goose deoxycholic acid (UDCA). Only a small amount enters the circulation. Two peaks of blood concentration occur 1 hour and 3 hours after oral administration.

 

Indications

Steroidal gallbladder stones - must be X-ray penetrable. Also, gallbladder contractile function must be normal. Cholestatic liver disease, bile reflux gastritis.

 

Contraindications

● Acute cholecystitis and cholangitis.

● Biliary obstruction (common bile duct and cystic duct) is contraindicated

● Contraindicated in severe hepatic hypoplasia

●Ursodeoxycholic acid powder should not be used if the gallbladder cannot be visualized on X-rays. If gallstones are calcified, if the gallbladder does not contract properly, and if there is frequent biliary colic.

 

FAQs:

1. What is Ursodeoxycholic Acid Powder?
Ursodeoxycholic acid powder (UDCA powder) is a naturally occurring hydrophilic bile acid used in pharmaceutical and healthcare applications. It is a white or off-white powder with high purity and good stability. Chemically known as 3α,7β-dihydroxy-5β-cholestane-24-acid, it is mainly used as an active pharmaceutical ingredient (API) in liver health formulations and bile acid-related products. Guanjie Biotech supplies high-quality ursodeoxycholic acid powder with an assay of more than 99%, tested by HPLC.

2. What is the purity of Ursodeoxycholic Acid Powder?
Guanjie Biotech provides ursodeoxycholic acid powder with high purity. The assay is typically above 99%, and each batch is tested using HPLC analysis to ensure quality and consistency. The product complies with strict quality standards, including identification, impurity control, heavy metal limits, residual solvent testing, and other key specifications. A complete COA is available for customers to verify product quality before use.

3. How is Ursodeoxycholic Acid Powder tested for quality?
Quality testing of ursodeoxycholic acid powder includes multiple analytical methods. HPLC is used to determine assay and impurity profiles. Other tests include infrared identification, loss on drying, melting point, specific optical rotation, heavy metals, residual solvents, lithocholic acid, chenodeoxycholic acid, and total impurities. These tests help ensure that each batch meets pharmaceutical-grade quality requirements.

4. What are the main applications of Ursodeoxycholic Acid Powder?
Ursodeoxycholic acid powder is widely used in pharmaceutical, nutraceutical, and healthcare industries. It is commonly used in formulations related to liver health, bile acid metabolism, gallbladder health, and cholesterol management. UDCA is also used as a raw material for developing tablets, capsules, and other healthcare products. Its unique bile acid properties make it an important ingredient in liver support formulations.

5. What are the benefits of Ursodeoxycholic Acid Powder?
Ursodeoxycholic acid powder is known for its role in supporting normal bile flow and maintaining bile acid balance. It can help improve bile composition by increasing hydrophilic bile acids and reducing the impact of more hydrophobic bile acids. Research has also explored its effects on liver protection, cholesterol metabolism, anti-inflammatory activity, and cellular protection mechanisms.

6. Is Ursodeoxycholic Acid Powder soluble in water?
No, ursodeoxycholic acid powder is generally insoluble in water. It is soluble in ethanol, glacial acetic acid, and sodium hydroxide solution. It is also slightly soluble in acetone and insoluble in some organic solvents such as trichloromethane. Proper formulation techniques are required when developing products containing UDCA powder.

7. How should Ursodeoxycholic Acid Powder be stored?
Ursodeoxycholic acid powder should be stored in a cool, dry, and well-sealed environment. It should be protected from moisture, excessive heat, and direct sunlight to maintain stability and quality. Bulk packaging options can be customized according to customer requirements, making it suitable for long-term storage and global transportation.

8. Where does ursodeoxycholic acid come from?

A:The reason why it is called ursodeoxycholic acid is because it was first found in bear bile. Bears, had to be unlucky. But after all, taking bile from live bears is too cruel and won't last long. It is now possible to synthesize ursodeoxycholic acid from bile acids, goose deoxycholic acid and pig deoxycholic acid by chemical synthesis. Ursodeoxycholic acid powder can also be synthesized from bacteria using biosynthesis.

 

Factory&Team:

Factory&Team

 

Certification

Certification

 

Package & Shipment

Package & Shipment

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