Sinoway Industrial Co., Ltd

Date: 9th May 2016
Atracurium Besylate
Sinoway Industrial Co.,Ltd is a famous China atracurium besylate manufacturer and supplier,Website:http://www.sinoway-chem.com, welcome to buy GMP and EP atracurium besylate from us and check the price with us.Basic information ofAtracurium besylate:NameAtracurium besylateAliasCAS NO.64228-81-5Molecular FormulaC65H82N2O18S2Molecular Weight1243.48QualityStandardCurrent USPPackage Size2kg or 3kg/tin/cartonStorage conditionPreserve in tight,light-resistant containers and store at 2-8℃Use of Atracurium besylate:Atracurium is indicated as an adjunct to general anesthesia to produce muscle relaxation during surgical procedures or mechanical ventilation and also to facilitate endotracheal intubation. Atracurium can be used in patients with significant renal or hepatic disease.COA ofAtracurium Besylate :TESTSTANDARDRESULTDescriptionwhite to off-white powder,White powderSolubilityVery soluble in acetonitrile, in alcohol, and in methylene chloride; soluble in waterConformsIdentificationA.IR spectrum of the sample should correspond to that of the Reference StandardConformsB.The retention times of the three main isomeric peaks of the sample solution correspond to those of the standard solution, as obtained in the assayConformsWaterNMT 5.0%1.4%Clarity and Color of SolutionThe solution is clear and not more intensely colored than standard solutionConformsResidue on ignitionNMT 0.1%0.06%Heavy MetalsNMT 20ppm?20ppmImpurity JNMT 0.001%?0.001%Related SubstancesImpurity A(containing A1 and A2): Not more than 1.5%0.48%Impurity B: Not more than 0.1%?0.006%Impurity C(containing C1 and C2): Not more than 1.0%0.25%Impurity D(containing D1 and D2): Not more than 1.5%0.25%Impurity E: Not more than 1.5%?0.05%Impurity F: Not more than 1.0%?0.05%Impurity G: Not more than 1.0%0.09%Total of Impurity H,I and K:Not more than 1.0%:0.10%Tetrahydropapaverine: Not more than 0.10%?0.05%Any other individual impurity: Not more than 0.1%?0.05%Total impurities: Not more than 3.5%(Disregard any impurity less than 0.05%)1.2%Microbial LimitTotal aerobic bacteria: Not more than 100CFU/g?1cfu/gMold and yeast: Not more than 10CFU/g?1cfu/gE. coli. :should be absent in each 1gNon-detectedBacterial EndotoxinNot more than 2.0EU/mg?2.0EU/mgResidue SolventsEther: Not more than 5000ppm?3ppmAcetone: Not more than 5000ppm?8ppmEthyl acetate: Not more than 5000ppm?16ppmDichloromethane: Not more than 600ppm66ppmEthanol: Not more than 5000ppm?18ppmAcetonitrile: Not more than 410ppm10ppmToluene: Not more than 890ppm73ppmAssayContain 97.0% to 102.0% of C65H82N2O18S2on the anhydrous basis98.3%Trans-trans isomer:5.0%-6.5%5.5%Cis-trans isomer: 34.5%-38.5%35.9%Cis-cis isomer:55.0%-60.0%58.6%ConclusionConfirms to current USP standard.
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