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100% Original Rivaroxaban 366789-02-8 - Ursodeoxycholic acid 128-13-2 Digestive system Cholagogic – Neore

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100% Original Rivaroxaban 366789-02-8 - Ursodeoxycholic acid 128-13-2 Digestive system Cholagogic – Neore Detail:

Payment: T/T, L/C
Product Origin: China
Shipping Port: Beijing/Shanghai/Hangzhou
Production capacity: 2000kg/month
Order(MOQ): 25kg
Lead Time: 3 Working Days
Storage condition: Stored in cool, dry place, room temperature.
Package material: drum
Package size: 25kg/drum
Safety information:  Not dangerous goods

Ursodeoxycholic acid

Introduction

Ursodeoxycholic acid (UDCA), also known as ursodiol, is a secondary bile acid, produced in humans and most other species from metabolism by intestinal bacteria. It is synthesized in the liver in some species, and was first identified in bear bile, which is the derivation of its name Ursus. In purified form, it has been used to treat or prevent several diseases of the liver or bile ducts.

UDCA has been used as medical therapy in gallstone disease (cholelithiasis) and for biliary sludge. UDCA helps reduce the cholesterol saturation of bile and leads to gradual dissolution of cholesterol-rich gallstones.

UDCA may be given after bariatric surgery to prevent cholelithiasis, which commonly occurs due to the rapid weight loss producing biliary cholesterol oversaturation and also biliary dyskinesia secondary hormonal changes.

Specification (EP10)

Item

Specification

Appearance

White or almost white powder

Solubility

Practically insoluble in water, freely soluble in ethanol (96%), slightly soluble in acetone, practically insoluble in methylene chloride

Melting point

202-204℃

Identification

Same IR spectrum as ursodeoxycholic acid CRS
The principal spot in the chromatogram obtained with the test solution (b) is similar in position, colour and size to the principle spot in the chromatogram obtained with reference solution (a).
The suspension obtained is greenish-blue.
Specific optical rotation

+58.0~+62.0°

Impurity C

Lithocholic acid ≤ 0.1%

Related substance (HPLC)

impurity A: chenodeoxycholic acid ≤ 1.0%

unspecified impurities ≤ 0.1%

total ≤ 1.5%

Heavy metals

ICH Q3D

Loss on drying

≤ 1.0%

Sulphated ash

≤ 0.1%

Assay

99.0%~101% (Dried substance)

Residual solvents

Acetone ≤ 5000 ppm

Ethyl acetate ≤ 5000 ppm

Isopropanol ≤ 5000 ppm

Ethanol ≤ 5000 ppm

Microbiological Tests

Total aerobic microbial count ≤ 10³CFU/g

Total yeasts and moulds count ≤ 10²CFU/g

Escherichia coli: Absent in 1 g

Salmonella: Absent in 10 g

Additional properties  
Particle size distribution

100% pass number 180 sieve (100% pass 80 mesh sieve)


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