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Product Name: API Ursodeoxycholic Acid/ Ursodiol / Udca /CAS 128-13-2/Ep6.0/Ep8.0/USP/Bp in Stock Model NO.: ep/usp/bp CAS: 128-13-2 Trademark: top Transport Package: 1kg/Bag; 25kg/Drum Specification: EP8.0, EP9.0, EP6.0, USP Origin: China HS Code: 2918190090 Product Description Product DescriptionUrsodeoxycholic AcidUrsodeoxycholic Acid CAS NO.:128-13-2 Source: synthesized from chenodeoxycholic acid Quality standard: EP6.0;EP8.0=EP9.0 Effect and use: it has the function of regulating liver function, dissolving gallstone and so on. Ursodeoxycholic acid CAS 128-13-2Ursodeoxycholic acidCAS 128-13-2Brand: HyperMF C24H40O4EINECS 204-879-3MW 392.57Min order: 10gramsCategories:Bile Acids;Biochemistry;Steroids;Intermediates &Fine Chemicals;Pharmaceuticals;API's;API;Herb extractUsageUrsodeoxycholic acid, Used as an anticholelithogenic. Epimer with Chenodiol with respect to the hydroxyl group at C7.ApplicationsUrsodeoxycholic acid ,Pharmaceutical raw materialsChemical PropertiesAppearance:white crystalline powderMolecular Weight:392.58Density:1.128 g/cm3Boiling Point:547.1 °C at 760mmHgMelting Point:203-206ºCFlash Point:298.8 °CAlpha:60 o(C=2, ETOH)Storage Temperature:Store in atightly closed container. Store in acool, dry area away from incompatible substances.Refractive index:60.5 °(C=2, EtOH)Solubility:practically insoluble in waterStability:Stable under normal temperatures and pressures.Introduction:1.product Name: Ursodeoxycholic Acid2.CAS No.: 128-13-23. Other Names: UDCA4. MF: C24H40O45..Purity: 99% min6..Appearance:White or almost white crystal powderUrsodeoxycholic acid is white crystal powder,almost insoluble in water,freely soluble in alcoholUrsodeoxycholic acid (UDCA), also known as ursodiol, is acompound produced from bile by the action of intestinal bacteria. Since this bile acid is not produced directly by the body, it is known as asecondary bile acid.One of the functions of bile acids is to act in the intestine to help digest fats and fatsoluble vitamins from food. Ursodeoxycholic acid has been used in pharmacology to dissolve gallstones made of cholesterol, and to treat liver disorders. It has been used for along time in both human and veterinary medicine.Function:Ursodeoxycholic acid can be chemically synthesized. Ursodeoxycholic acid reduces cholesterol absorption and is used to dissolve (cholesterol) gallstones in patients who want an alternative to surgery. The drug is very expensive, however, and if the patient stops taking it, the gallstones tend to recur if the condition that gave rise to their formation does not change. For these reasons, Ursodeoxycholic acid has not supplanted surgical treatment by cholecystectomy.UDCA is used to treat primary biliary cirrhosis. In children, its use is not licensed, as its safety and effectiveness are not established. Ursodeoxycholic acid reduces elevated liver enzyme levels by facilitating bile flow through the liver and protecting liver cells.Usage:Used as an anticholelithogenicCOACERTIFICATE OF ANALYSISURSODEOXYCHOLIC ACIDBatch NO.: 190216 Quantity: 5000KGDate of Production:28th, Feb., 2019 Validity:27th Feb.,2021Test itemTest standardTest resultAppearanceWhite or almost white crystalline powder, taste bitter, without stinkCompliedIdentificationEnterprise StandardCompliedRelated SubstanceLithocholic Acid≤0. 1%CompliedSpecific Optical Rotation+58° -+62°+62°Melting Point200ºC -204ºC202.9ºC-203.9ºCLoss on Drying≤1.0%0.11%Ignition Residue≤0.1%0.08%Heavy Mental≤10ppmCompliedAssay (Titration)≥99.0%-101%100.4%Purity (HPLC)CDCA≤1.0%Other Max. Individual Impurity≤0.1%Total Impurity≤1.5%CDCA:Not detectedOther Max.Individual Impurity:0.08%Total Impurity:0.21%Conclusion: This article Ursodeoxycholic acid is in conformity with EP8.0.Inspector: Chen chao Examine:Wu Li Q.A Manager: Li GuojunMSDSHefei Joye import Export Co.,LtdMaterial Safety Data SheetUrsodeoxycholic acid, 99% Section 1- Chemical Product and Company IdentificationMSDS Name:Ursodeoxycholic acid, 99% Catalog Numbers:AC208590000, AC208590010, AC208590050, AC9867724, XXAC20859-20Synonyms:Cholan-24-oic acid, 3,7-dihydroxy-, (3-alpha,5-beta,7-beta)-; 3-alpha, 7-beta-Dihydroxycholanic acid; 3,7-Dihydroxycholan-24-oic acid; 3-alpha, 7-beta-Dihydroxy-5-beta-cholanoic acid; 3-alpha, 7-beta-Dioxycholanic acid; 7-beta-Hydroxylithocholic acid; 17-beta-(1-Methyl-3-carboxypropyl) etiocholane-3-alpha, 7-beta-diol; Ursodesoxycholic acid; UDCACompany Identification: Company Name: HEFEI JOYE import EXPORT CO., LTDCompany address:1006 room. 2#, xihuanzhongxin pazzle, Huangshan Road 518#, Shushan district, Hefei. Anhui ChinaFor information, call:0086-55165674590Emergency Number:0086-18715606860Section 2- Composition, Information on IngredientsCAS#Chemical NamePercentEINECS/ELINCS128-13-2Ursodeoxycholic acid99%204-879-3Section 3- Hazards IdentificationEMERGENCY OVERVIEWAppearance: white powder.Caution!May cause eye and skin irritation. May cause respiratory and digestive tract irritation. This substance has caused adverse reproductive and fetal effects in animals.Target Organs:No data found.Potential Health EffectsEye:May cause eye irritation.Skin:May cause skin irritation.Ingestion:May cause irritation of the digestive tract.Inhalation:May cause respiratory tract irritation.Chronic:No information found.Section 4- First Aid MeasuresEyes:Flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Get medical aid.Skin:Get medical aid. Flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Wash clothing before reuse.Ingestion:Never give anything by mouth to an unconscious person. Get medical aid. Do NOT induce vomiting. If conscious and alert, rinse mouth and drink 2-4 cupfuls of milk or water.Inhalation:Remove from exposure and move to fresh air immediately. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical aid.Notes to Physician:Treat symptomatically and supportively.Section 5- Fire Fighting MeasuresGeneral Information:As in any fire, wear aself-contained breathing apparatus in pressure-demand, MSHA/NIOSH (approved or equivalent), and full protective gear. During afire, irritating and highly toxic gases may be generated by thermal decomposition or combustion.Extinguishing Media:Use dry chemical, carbon dioxide, or appropriate foam.Flash Point:Not applicable.Autoignition Temperature:Not applicable.Explosion Limits, Lower:Not available.Upper:Not available.NFPA Rating:(estimated) Health: 0; Flammability: 0; Instability: 0Section 6- Accidental Release MeasuresGeneral Information:Use proper personal protective equipment as indicated in Section 8.Spills/Leaks:Sweep up, then place into asuitable container for disposal. Avoid generating dusty conditions. Provide ventilation.Section 7- Handling and StorageHandling:Wash thoroughly after handling. Remove contaminated clothing and wash before reuse. Use with adequate ventilation. Minimize dust generation and accumulation. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation.Storage:Store in atightly closed container. Store in acool, dry area away from incompatible substances.Section 8- Exposure Controls, Personal ProtectionEngineering Controls:Facilities storing or utilizing this material should be equipped with an eyewash facility and asafety shower. Use adequate ventilation to keep airborne concentrations low.Exposure LimitsChemical NameACGIHNIOSHOSHA -Final PELsUrsodeoxycholic acidnone listednone listednone listedOSHA Vacated PELs:Ursodeoxycholic acid: No OSHA Vacated PELs are listed for this chemical.Personal Protective EquipmentEyes:Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA's eye and face protection regulations in 29 CFR 1910.133 or European Standard EN166.Skin:Wear appropriate protective gloves and clothing to prevent skin exposure.Clothing:Wear appropriate protective clothing to minimize contact with skin.Respirators:A respiratory protection program that meets OSHA's 29 CFR 1910.134 and ANSI Z88.2 requirements or European Standard EN 149 must be followed whenever workplace conditions warrant respirator use.Section 9- Physical and Chemical PropertiesPhysical State:PowderAppearance:whiteOdor:None reported.pH:Not available.Vapor Pressure:Not available.Vapor Density:Not available.Evaporation Rate:Not available.Viscosity:Not available.Boiling Point:Not available.Freezing/Melting Point:200.00 -205.00 deg CDecomposition Temperature:Not available.Solubility:practically insolubleSpecific Gravity/Density:Not available.Molecular Formula:C24H40O4Molecular Weight:392.57Section 10 -Stability and ReactivityChemical Stability:Stable under normal temperatures and pressures.Conditions to Avoid:Incompatible materials.Incompatibilities with Other Materials:Oxidizing agents.Hazardous Decomposition Products:Carbon monoxide, carbon dioxide, acrid smoke and fumes.Hazardous Polymerization:Will not occur.Section 11 -Toxicological InformationRTECS#: CAS#128-13-2: FZ2000000LD50/LC50:CAS# 128-13-2: Oral, mouse: LD50 =>10 gm/kg; Oral, rat: LD50 =4600 mg/kg;.Carcinogenicity:CAS# 128-13-2: Not listed by ACGIH, IARC, NTP, or CA Prop 65.Epidemiology:No information foundTeratogenicity:Teratogenic effects have occurred in experimental animals.Reproductive Effects:Adverse reproductive effects have occurred in experimental animals.Mutagenicity:Mutation in microorganisms: Salmonella typimurium =40 mg/L.Neurotoxicity:No information foundOther Studies:Section 12 -Ecological InformationEcotoxicity:No data available. No information available.Environmental:No data available.Physical:No data available.Other:None.Section 13 -Disposal ConsiderationsChemical waste generators must determine whether adiscarded chemical is classified as ahazardous waste. US EPA guidelines for the classification determination are listed in 40 CFR Parts 261.3. Additionally, waste generators must consult state and local hazardous waste regulations to ensure complete and accurate classification.RCRA P-Series:None listed.RCRA U-Series:None listed.Section 14 -Transport InformationUS DOTShipping Name:Not regulated as ahazardous materialHazard Class:UN Number:Packing Group:Section 15 -Regulatory InformationUS FEDERALTSCACAS# 128-13-2 is not listed on the TSCA inventory. It is for research and development use only.Health &Safety Reporting List None of the chemicals are on the Health &Safety Reporting List.Chemical Test Rules None of the chemicals in this product are under aChemical Test Rule.Section 12b None of the chemicals are listed under TSCA Section 12b.TSCA Significant New Use Rule None of the chemicals in this material have aSNUR under TSCA.CERCLA Hazardous Substances and corresponding RQs None of the chemicals in this material have an RQ.SARA Section 302 Extremely Hazardous Substances None of the chemicals in this product have aTPQ.Section 313 No chemicals are reportable under Section 313.Clean Air Act: This material does not contain any hazardous air pollutants. This material does not contain any Class 1Ozone depletors. This material does not contain any Class 2Ozone depletors.Clean Water Act: None of the chemicals in this product are listed as Hazardous Substances under the CWA. None of the chemicals in this product are listed as Priority Pollutants under the CWA. None of the chemicals in this product are listed as Toxic Pollutants under the CWA.OSHA: None of the chemicals in this product are considered highly hazardous by OSHA.STATE CAS# 128-13-2 is not present on state lists from CA, PA, MN, MA, FL, or NJ.California Prop 65California No Significant Risk Level: None of the chemicals in this product are listed.European/International RegulationsEuropean Labeling in Accordance with EC DirectivesHazard Symbols: Not available.Risk Phrases:Safety Phrases: S 24/25 Avoid contact with skin and eyes.WGK (Water Danger/Protection) CAS# 128-13-2: No information available.Section 16 -Additional InformationThe information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for theirparticular purposes. In no event shall Fisher be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, however arising, even if Fisher has been advised of the possibility of such damages.REPORTED BY :Hefei Joye import Export Co.,LtdContact:Jenny LuMobile:+86/0086 18715606860