Ursodeoxycholic acid API

CAS No: 128-13-2
Appearance: White to almost-white powder
Standard: USP/EP/JP/CP
Supply Ability:2000kg per month
Shelf Life: Two years
Payment: T/T, LC or DA
Delivery Time: Ready Stock in Local Warehouse, 1-3 days
Origin: China
Shipping: DHL, FedEx, TNT, EMS, By Sea, By Air
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Product Introduction

We supply Ursodeoxycholic acid API

We specialize in furnishing Ursodeoxycholic acid API that meets the loftiest quality norms. Ursodeoxycholic acid (UDCA) is a corrosiveness acid used in the treatment of liver and gallbladder diseases, similar as primary biliary cirrhosis and gallstones. Our product is produced under strict quality control and tested for chastity and energy. We insure that our Ursodeoxycholic acid is of the loftiest quality, dependable, and safe for use. Our platoon of experts is committed to furnishing prompt and effective client service. With us, you can be confident that you're getting the stylish Ursodiol API available on the request.

 

What's Ursodeoxycholic acid ?

Ursodeoxycholic acid, also known as UDCA,Ursodiol,  is a medicinal component extensively used in the treatment of liver and gallbladder diseases. It's a naturally being corrosiveness acid that has been insulated from the corrosiveness of bears known for their hibernating habits.

its chemical name is 3a, 7 β- dihydroxy- 5 β- cholestane-24-acid, is an organic emulsion, odorless, and bitter in taste. In drug, it's used to increase the stashing of corrosiveness acids, change the composition of corrosiveness, reduce cholesterol and cholesterol lipids in corrosiveness, and grease the gradational dissolution of cholesterol in gallstones.

 

Basic Information

Product Name: Ursodeoxycholic acid

CAS:128-13-2

MF:C24H40O4

MW:392.57

EINECS:204-879-3

MDL No.:MFCD00003680

Structural formula:

product-1-1

Origin: China

Application: Cholestasis

Delivery Time: in stock

 

Technical Specification

ITEM

SPECIFICATIONS

RESULTS

Appearance

White or almost white powder

Light yellow,hygroscopic powder

 

Solubility

Practically insoluble in water,free soluble in
ethanol (96%),slightly soluble in acetone,

practically insoluble in methylene chloride.

Conforms

mp

200-204℃

201-202℃

IDENTIFICATION

A.Infrared absorption spectrophotometry (2.2.24)

Comparison:ursodeoxycholic acid CRS

Conforms

B.Examine the chromatograms obtained in the test for impurity C.

The principal spot in the chromatogram obtained colour and size to the principle spot in the chromatogram obtained with reference solution (a)

Conforms

C.Dissolve about 10 mg in 1 mL of sulfuric acid R. Add 0.1 mL of formaldehyde solution R and allow to stand for 5 min.Add 5 mL of water R

The suspension obtained is greenish-blue.

Positive reaction

TESTS

Specific optical rotation(2.2.7),dried substance

+58.0~+62.0

+61.0

Impurity C(2.2.27):lithocholic acid

≤0.1%

<0.1%

Related substances (HPLC)(2.2.29)

 

 

impurity A: chenodeoxycholic acid

≤1.0%

0.1%

unspecified impurities

≤0.1%

<0.10%

Total

≤1.5%

0.21%

Heavy metals(2.4.8)

ICH Q3D

Conforms

Loss on drying (2.2.32)

≤1.0%

0.19%

Sulfated ash (2.4.14)

≤0.1%

0.07%

ASSAY (HPLC),dried substance

99.0%-101.0%

99.8%

ADDITIONAL PROPERTIES

Particle size distribution (Sieve Test,2.9.12)

Not less than 95 per cent by mass passes through a number 180 sieve and not more than 40 per cent by mass passes through a number 125 sieve

Conforms

Bulk density (2.9.34)

0.50-0.60 g/mL

0.55 g/mL

Tapped density (2.9.34)

0.60-0.75 g/mL

0.75 g/mL

RESIDUAL SOLVENTS (2.4.24)&(5.4)

Acetone

≤5000 ppm

30 ppm

Ethyl acetate

≤5000 ppm

0 ppm

Isopropanol

≤5000 ppm

0 ppm

Ethanol

≤5000 ppm

310ppm

MICROBIOLOGICALTESTS (2.6.12)&(2.6.13)

Total Plate Count

<10³cfu/g

301cfu/g

Yeasts and Molds

<10²cfu/g

<10cfu/g

Salmonella

Absence in 10 g

Absence in 10 g

E.Coliform

Absence in 1g

Absence in 1g

CONCLUSION:THE TEST RESULTS CONFORM TO EP9.0

Package: 1kg; 25kg

Storage: Room temperature,protect from light,air tight.

Shelf Life 24 months

 

Application

The Application of Ursodeoxycholic acid API is primarily used in the treatment of liver conditions, similar as primary biliary cirrhosis( PBC) andnon-alcoholic adipose liver complaint( NAFLD). It's also used in the treatment of gallstones, both to dissolve and help the conformation of new bones.

UDCA provides a number of remedial benefits in the treatment of these conditions. It not only helps to reduce inflammation and inhibit the progression of liver cirrhosis, but it also promotes the rejuvenescence of liver cells and helps to ameliorate the overall function of the liver. also, it aids in the immersion and excretion of cholesterol, reducing the threat of gallstone conformation.

In addition to its remedial parcels, Ursodeoxycholic acid (UDCA) is also used as a salutary supplement and is generally set up in health food stores. It's believed that UDCA may help to cover the liver from damage caused by poisons and other environmental factors.

Overall, Ursodiol API is an important medicinal component with a range of Applications in the treatment of liver and gallbladder diseases. Its remedial parcels help to promote liver health and help the development of serious conditions, making it an essential aspect of ultramodern drug.

 

Chemical property

Ursodeoxycholic acid is a white greasepaint; No odor, bitter taste. Mp200- 204 ℃. It's answerable in ethanol and glacial acetic acid, answerable in sodium hydroxide test result, and undoable in chloroform. UDCA is an isomer of CDCA, with a stronger litholytic effect than CDCA, and no diarrhea or liver toxin. UDCA can reduce the immersion of cholesterol, as well as the conflation of cholesterol and the cholesterol content in corrosiveness. also, UDCA can also reduce the list scrap of concanavalin A, which can promote the conformation of corrosiveness chargers and inhibit the conformation of monuments. The combination of UDCA and CDCA can enhance the dissolution effect of individual use and reduce side goods. The combination of the two is substantially used to treat cholesterol gallstones in the gallbladder. When the viscosity of gallstones and corrosiveness in cases is equal or the CT value of gallstones is lower than 75 units, UDCA has the fastest dissolution rate. After using this product, cases with gallstones can increase their supplemental platelet count.

 

Production methods

Method 1:

Preparation of 3 α, 7 α- diacetylcholic acid methyl ester using chenodeoxycholic acid as raw material. Take 36 ml of anhydrous methanol, introduce 1g of dry hydrogen chloride gas, add 12g of cholic acid, stir, heat and influx for 20- 30 twinkles, let it stand at room temperature for several hours, precipitate chargers, snap, sludge, marshland with ether, dry, and gain methyl cholic acid. Take 2g of methyl gallate, add9.6 ml of benzene,2.4 ml of pyridine,2.4 ml of acetic anhydride, shake for 10- 15 twinkles, and let it stand at room temperature for 20 hours. Pour the response result into 100 ml of water, remove the benzene subcaste, marshland constantly with distilled water, recover the detergent, wash the solid residue with petroleum ether formerly, and recrystallize with methanol water result to gain 3 α, 7 α- diacetylcholic acid methyl ester. Preparation of Cholic Acid → Methyl Cholate → 3 α, 7 α- Diacetylcholic Acid Methyl Ester Goose Deoxycholic Acid Take1.5 g of Diacetylcholic Acid Methyl Ester, add 24 ml of acetic acid, add potassium chromate result(0.76 g of potassium chromate is dissolved in1.8 ml of water), heat to 40 ℃, reply for 8 hours, add 120 ml of water, shake for a moment, let it stand for 12 hours, sludge, wash with distilled water to neutral, dry, and gain 3 α, 7 α- Diacetoxy-12-ketocholic Acid Methyl Ester, shortened as 12- ketone. Take 15g of 12- ketone, add 150 ml of diethylene glycol ether, add 15 ml of 80% hydrazine hydrate result, add 15g of potassium hydroxide, heat to 30 ° C and influx for 15h, heat to 195- 200 ° C and influx for2.5 h, heat to 217 ° C and reply for a moment, cool to 190 ° C, add0.7 ml of hydrazine hydrate result, heat from 215 ° C to 220 ° C within 3 hours, cool, add 600 ml of distilled water, acclimate pH to 3 with 10% sulfuric acid, precipitate chargers, sludge, wash to neutral, add ethyl acetate, discard the water subcaste, wash the organic subcaste with water 1- 2 times, and distill under reduced pressure to gain white 3 α, 7 α- dihydroxycholic acid. Goose deoxycholic acid. Preparation of 3 α, 7 α- Diacetylcholic Acid Methyl Ester → 3 α, 7 α- Diacetoxy-12-ketocholic Acid Methyl Ester → 3 α, 7 α- Dihydroxycholic Acid( UDCA) High quality UDCA Take 2g of UDCA, add 100 ml of acetic acid, add 20g of potassium acetate, shake to dissolve, add1.5 g of potassium chromate( dissolved in 10 ml of water), leave overnight at room temperature, add 200 ml of water, precipitate chargers, sludge, marshland with water, dry to gain 3 α- hydroxy- 7ketocholic Acid. Take 4g of 3 α- hydroxy-7-ketocholic acid, add 100 ml of n- butanol, heat to about 115 ℃, add 8g of metallic sodium in batches, gradationally precipitate a white slurry, continue the response for 30 twinkles, add 120 ml of water, stir and heat to dissolve transparent, reduce pressure to dematerialize the organic subcaste, add 500 ml of water to the residue, dissolve, sludge, add 10% sulfuric acid to acclimate pH 3, precipitate a white flocculent substance, sludge, marshland with water to neutral, dry, wash with ethyl acetate, and solidify with dilute ethanol to gain 3 α, 7 β- dihydroxycholic acid, which is the high- quality product of ursodeoxycholic acid. Goose deoxycholic acid( potassium chromate) → 3 α- hydroxy-7-ketocholic acid( metallic sodium, 115 ℃) → 3 α, 7 β- dihydroxycholic acid( ursodeoxycholic acid)

 

Method 2:

Using gormandizer corrosiveness swab or gormandizer corrosiveness as raw accoutrements , separate ursodeoxycholic acid from gormandizer corrosiveness swab or gormandizer corrosiveness using thin- subcaste chromatography. Pig corrosiveness mariners contain both free and set UDCA, with a content of roughly 30%; Pig corrosiveness contains conjugated UDCA, with a content of roughly0.6%.

 

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Yihui company as a beacon of trust in the pharmaceutical industry, consistently delivering high-quality Ursodeoxycholic acid API that aligns with international standards. Our ISO, Kosher, Halal certifications underscore our commitment to excellence. For inquiries and purchases, please contact us at sales@yihuipharm.com.

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