Ursodeoxycholic Acid Manufacturers

Ursodeoxycholic Acid Manufacturers:

Guanjie is one of most powderful Ursodeoxycholic Acid Manufacturers. We are specilizing in UDCA powder researching, producing and trading. It is white or off-white powder, which the assay can be extent to 99%. In order to ensure the quality, we have our own testing researchers and the third party testing center to test it by HPLC and other testing methods. High quality product and competitive price, welcome to enquiry us.

 

Why Choose Guanjie?

● Two independent factories and three production line.

● Professional and efficient after-sale service.

● Provide the third party testing.

● Provide customized packing service

● Have strong Collaborators:Northwestern University and Chinese Academy of Sciences research center

 

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%	0.38%
Melting Point	200°C~204°C	200.2°C~201.0°C
Heavy Metal	≤20ppm	Complies
Specific Optical Rotation	+58.0°~+62.0°	+59.4°
Lithocholic acid	≤0.1%	Comlies
Chenodeoxycholic acid	≤1.0%	0.03%
Single Impurity	≤0.1%	0.05%
Total Impurities	≤1.5%	0.22%
Assay	99.0%~101.0%	100.1%
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

 

Production process

● Extraction:

UDCA can be extracted from the bile of bears or other animals, but this method is not sustainable or ethical. Therefore, synthetic UDCA is usually produced by chemical synthesis. The starting material is usually chenodeoxycholic acid, which is extracted from bovine bile or prepared synthetically from cholesterol. The extraction involves dissolving the chenodeoxycholic acid in a solvent such as tetrahydrofuran or dimethylformamide.

 

● Synthesis:

The extracted chenodeoxycholic acid is then subjected to a series of chemical reactions that transform it into UDCA. The reactions typically involve oxidation, reduction, and isomerization steps, and are monitored by various analytical techniques such as high-performance liquid chromatography (HPLC) and nuclear magnetic resonance (NMR) spectroscopy.

 

● Purification:

After synthesis, the UDCA product is usually purified by chromatography, which separates the various isomers of UDCA from impurities and byproducts. This step is critical to ensuring the purity, quality, and consistency of the final UDCA product.

 

● Drying:

The purified UDCA is then dried to remove any remaining moisture and obtain a powder form. This can be done by various methods such as spray drying or lyophilization, which involve atomizing the liquid UDCA into a hot air stream or freezing it and then removing the ice by sublimation, respectively.

 

● Packaging:

Finally, the UDCA powder is packaged into suitable containers, such as glass bottles or plastic bags, and stored in a dry, cool place until it is ready for use. The packaging should be labeled with the product name, batch number, expiration date, and other relevant information in compliance with regulatory requirements.

 

Flow chart:

 

 

Ros:

 

Testing Methods:

There are several methods to test the purity and quality. And Ursodeoxycholic Acid Manufacturers should do following methods. It includes:

 

● HPLC:

High-performance liquid chromatography (HPLC) is a widely used method to test the purity of Urosodeoxycholic Acid. This method separates and analyzes the different components of a sample based on their physical and chemical properties.

 

● FT-IR:

Fourier Transform Infrared Spectroscopy (FT-IR) is a reliable method to check the quality of UDCA Powder. It helps to identify the functional groups present in the compound and detect any impurities.

 

● NMR:

Nuclear Magnetic Resonance Spectroscopy (NMR) is a non-destructive method to determine the structure and purity of organic compounds like Urosodeoxycholic Acid. It provides detailed information about the chemical environment and bonding of the atoms in the sample.

 

● Mass Spectrometry:

Mass spectrometry is a powerful analytical technique to identify the molecular weight and composition of a compound. It is useful to check the purity and identify any impurities in Urosodeoxycholic Acid powder.

 

Factory&Team：

 

Certification

 

Package & Shipment

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