UDCA Powder

UDCA Powder Supplier:

Guanjie Biotech is a high-quality UDCA powder supplier. It is a white or off-white powder that is used for its various health benefits. The purity of the supplement is verified using HPLC, ensuring that it meets the highest quality standards. It is Insoluble in water and methylene chloride, freely soluble in ethanol and ,slightly soluble in acetone. Our competitive products, if you want to buy UDCA, please feel free to quote us at info@gybiotech.com.

Why Choose Guanjie?

● We can do the third party test.

● We guarantee the quality is in conformity with the Certificate of Analysis provided by us, if not, we accept 100% exchange, return back and refund.

● We can reply you within one hour for any inquire questions and complaint.

● We can do OEM/ODM, sachet package.

● Our products are certified with ISO 9001-22000, SC, KOSHER, HALAL.

 

Product Introduction:

UDCA is a bile acid that is produced naturally in the body. Bulk UDCA powder is used as a dietary supplement and medication to treat certain liver and gallbladder conditions, such as primary biliary cholangitis and gallstones. UDCA powder helps to improve bile flow, reduce inflammation and protect liver cells from damage. It can be taken orally in capsule or tablet form, or as a powder mixed with liquid.

 

COA

Product Name:
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

 

Extraction Methods:

UDCA powder Supplier use the following three methods to obtain the products. But Guanjie applies the enzymatic preparation.

 

● Bear bile extraction
After obtaining bear bile juice from live bears using the drainage technique, a process of extraction, separation, and purification is used to obtain the desired product. However, due to the inhumane and low-yielding nature of this traditional method, which relies on artificial breeding of live bears and has excessively long cycle times, other methods have been implemente.

 

● Chemical synthesis
UDCA powder is a widely used product in industrial production, can be synthesized using raw materials like bile acid (CA), porcine deoxycholic acid (HDCA), and goose deoxycholic acid (CDCA) derived from animals such as cattle, pigs, chickens, and ducks. development.

 

● Enzymatic preparation
By using CDCA as a raw material and employing the selective catalytic properties of biological enzymes, it can be produced through a two-step oxidation and reduction reaction. This process is simple, offers mild reaction conditions, high efficiency, and fewer impurities.We use it.

 

Flow Chart:

 

 

Testing Methods:

To ensure the quality of UDCA powder, We uses the following testing methods.

1. Burning residue -Standard:N MT0.1%

● Weigh and take a test sample. Take a sample of 1.0g, state it in a crucible ignited and dried to a constant weight , and weigh it preciously.

●Carbonization: Slowly burn the crucible filled with sample on oven( The sample should be prevented from expanding abruptly by heated or escaping by burning). Burn the sample to be completely carbonized to black,without any smoke. Cool it to indoor temperature.

 

Ashing: Drop in 0.5～1.0ml of sulfuric acid to wet the carbide.Continuously heat it on oven to dry the sulfate steam till the white smoke disappears completely( the operation above should be conducted in fume cupboard).Place the crucible in a high temperature furnace with the lid of the crucible oblique, burning around 60 minutes at 700～800℃ till the test UDCA powder sample completely ashed to constant weight. Test twice and get the average value.

 

●Formula

First test: weight of test sample：________ g;weight of empty crucible： ________ g;weight of residue and

crucible：________g;→result of analysis：________%

Second test：weight of test sample ：________g;weight of empty crucible：________g;weight of residue and

crucible：________g;→result of analysis：________%

 

2. Purity Analysis (Related substancesⅠ)-TLC  Standard: Lithocholic acid - NMT 0.1%

●Solvent mixture: water R, acetone R(10:90 V/V).

●Test solution(a).Dissolve 0.40 g of the substance to be examined in the solvent mixture and dilute to 10ml with the solvent mixture.

●Test solution(b).Dilute 1mL of test solution(a) to 10mL with the solvent mixture.

●Reference solution(a).Dissolve 40mg UDCA powder in the solvent mixture and dilute to 10mL with the solvent mixture.

●Reference solution(b). Dissolve 20mg of lithocholic acid CRS(impurity C) in the solvent mixture and dilute to 10.0mL with the solvent mixture( solution A). 

●Dilute 2.0ml of this solution to 100.0mL with the solvent mixture.

●Reference solution(c). To 5 mL of solution A, add 10mg of chenodeoxycholic acid CRS(impurity A) and dilute to 50 mL with the solvent mixture.

●Plate: TLC silica gel plate R.

●Mobile phase: glacial acetic acid R, acetone R, methylene chloride R (1:30:60 V/V/V).

●Application:5µL.

●Development: over 2/3 of the plate.

●Drying: at 120℃ for 10 min.

●Detection: spray immediately with a 47.6g/L solution of phosphomolybdic acid R in a mixture of 1 volume of sulfuric acid R and 20 volumes of glacial acetic acid R and heat at 120℃ until blue spots appear on a lighter background.

●System suitability: reference solution (c):

- The chromatogram shows 2 separated principal spots.

 

●Limit: test solution (a):

- Impurity C: any spot due to impurity C is not more intense than the principal spot in the chromatogram

obtained with reference solution (b) (0.1 per cent).

 

●Result

UCDA： The position of the spot by the test solution is the same as the reference solution.(Yes,No)

Lithocholic Acid(0.1%)： the spot by the test solution is______(deeper/lighter) than the one by the reference solution.

 

3. Analyze Purity(Related substances Ⅱ)-LC Standard: Related single impurity - NMT0.1%(Area%) Other impurities：NMT1.5%(Area%)

●Mobile phase： acetonitrile R： buffer solution R：methanol R=30：37：40

●Test solution preparation： dissolve 120 mg of the UDCA powder test sample by the diluent and volume 20 mL of the solution.

●Diluting the solution： methanol R： moving phase = 10:90 mixture

●buffer solution： sodium dihydrogen phosphate 0.78g. Dissolve it in 1 L of pure water and adjust the PH to 3 by phosphoric acid. 0.78g.

●When the quantity of mobile phase increases,the same concentration should be assured.

① Test condition: chromatographic column：4.6mm×250mm,5μmC18

② Temperature：40℃±1℃

③Detector:differential detector(RID)(35℃±1℃)

④ Flow rate：0.8ml/min(Retention time of UDCA about 15min)

⑤ Sample quantity：75μl

⑥Analysis time：60min

 

4.Assay by Titration Standard:99.0%-101.0%

● Weigh 0.350g(_____g;____g)(water content ________%) of the UDCA powder sample,dissolve UDCA Powder with 50ml of ethyl alcohol ( 96%) , add 0.2ml of indicating liquid, and add 50ml of water. Drop mol/L of NaOH titrating solution to titrate it to be pink. Consume NaOH titrating solution with a rate of ml; ____ml.

● In the same condition,titrate blank consumed NaOH titrant without adding test sample. _____ml.

● Test Condition

① Titrate solution: 0.1mol/L NaOH titrating solution：0.1mol/L

② Relative amount: 0.1mol/L NaOH titrating solution 1ml=39.258mgC24H40O4

 

●Formula

w：the assay of UDCA powder in test sample, %;

c：concentration of NaOH titrating solution, mol/L;

v1：the volume of consumed NaOH titrating solution for sample titrating,ml;

v0：the volume of blank consumed NaOH titrating solution, ml;

m：weigh and get the mass of test sample;

w0：the moisture content of test sample.

 

Factory&Team：

 

Certification

 

Package & Shipment

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