Obeticholic Acid CAS 459789-99-2

Obeticholic Acid CAS 459789-99-2 Basic information

Product Name:	Obeticholic Acid
Synonyms:	6-Ethylchenodeoxycholic aicd;3A, 7A -DIHYDROXY-6A -ETHYL-5B-CHOLAN-24-OIC ACID;Obeticholic acid 6-ECDCA;6alpha-Ethyl-chenodeoxycholic acid;6-Ecdca;6-Ethylchenodeoxycholic acid;6alph;Obeticholic Acid(INT 747,6-ECDCA)
CAS:	459789-99-2
MF:	C26H44O4
MW:	420.63
EINECS:	810-245-2
Product Categories:	Inhibitors;API;chemical
Mol File:	459789-99-2.mol

Obeticholic Acid CAS 459789-99-2 Chemical Properties

density:	1.091
Melting point:	108-110 °C
Boiling point:	562.9±25.0 °C(Predicted)
form:	White solid.
pka:	4.76±0.10(Predicted)

产品名称Product name	奥贝胆酸Obeticholic acid
CAS	459789-99-2	批号Batch No.	20200210
生产日期 Date of Manufacture	2020.02.10	报告日期Report Date	2020.02.18
有效期Expiry Date	2022.02.09	包装package	100G/Pack
执行标准Perform Standard	企业质量标准 Enterprise Standard

项目Items	标准规定Standard		检验结果Results
性状 Appearance	白色或类白色粉末 White or almost white powder		白色粉末White powder
溶解度Solubility	在甲醇中极易溶解，在异丙醇中易溶，在水中几乎不溶Very soluble in methanol, freely soluble in isopropanol, almost insoluble in water		Complies
鉴别Identification	（1）供试品溶液主峰的保留时间应与对照品溶液主峰的保留时间一致 The HPLC spectrum of the sample must be concordant with Test standard （2）供试品红外光吸收图谱应与对照品红外光吸收图谱一致 The IR absorption spectrum of the sample must be concordant with Test standard		符合规定Complies 符合规定 Complies
有关物质Related substances	单个未知杂质 Individual impurity substance ≤0.3% 总杂质 Total impurity substance ≤1.0%		0.19% 0.48%
水分 Water	不得过 3.0% NMT 3.0%		1.6%
炽灼残渣Residue on Ignition	不得过 0.2% NMT 0.2%		Complies
重金属Heavy metals	不得过 20ppm NMT 20ppm		Complies
残留溶剂Residual solvents	甲醇 Methanol≤3000ppm 乙醇 Ethanol≤5000ppm 正庚烷 N-heptane ≤5000ppm 乙酸正丁酯 N-butyl acetate≤5000ppm		Complies Complies Complies Complies
含量Assay	按无水物计算，应为 98.0%～102.0% on the anhydrous base, should be 98.0% ～102.0%		99.4%
结论 Conclusion	符合企业标准。 Complies with enterprise standard。

Obeticholic Acid Usage And Synthesis

Description

Obeticholic acid is a semi-synthetic bile acid analogue and acts as a farnesoid-X receptor (FXR) agonist. It is used for the treatment of primary biliary cholangitis. It is also under investigation for the treatment of other liver diseases,primary biliary cirrhosis, bile acid diarrhea and related disorders. Study has shown that it also has potential for treating nonalcoholicsteatohepatitis (NASH), and portal hypertension. Obeticholic acid takes effect through acting s the agonist of the farnesoid X receptor (FXR), which is the regulator of bile and cholesterol metabolism in the liver.

Indications and Usage

Obeticholic acid is also called 6-Ethylchenodeoxycholic acid. It is a new derivative of chenodeoxycholic acid (CDCA) in human primary bile acids, a natural ligand for farnesoid x receptors (FXR). Obeticholic acid was developed by American pharmaceutical company Intercept as the first drug to treat cholestatic liver disease in 20 years, and it is administered on patients that do not respond well to or cannot tolerate the old standard treatment drug ursodeoxycholic acid. Obeticholic acid has also been tested to treat a more common form of fatty liver – non-alcoholic fatty liver disease (NAFLD). Obeticholic acid can also be developed to treat other liver and intestine diseases.