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Sinoway Industrial Co.Ltd.
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Product name
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Cisatracurium besylate
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CAS No.
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96946-42-8
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Molecular Formula
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C53H72N2O12.2C6H5O3S
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Molecular Weight
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1243.49
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Quality Standard
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99% up, Medicine Grade, Injection Grade
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Appearance
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White powder
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COA of Cisatracurium besylate
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TEST
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STANDARD
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RESULT
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Appearance:
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white or almost white powder, slightly hygroscopic, ordorless
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Confirms
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Very solutable in acetonitrile or chloroform, Soluble in Water, very soluble and practically insolutable in ethyl ether
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Confirms
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Identification
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(1) IR
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Conforms
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(2) HPLC
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Conforms
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Water
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NMT 5.0%
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0.6%
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Residue on ignition
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NMT 0.2%
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0.1%
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Methyl benzenesulfonate
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NMT 0.1%
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undetected
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Toluene
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NMT 890ppm (ICH)
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102ppm
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Chromatographic purity
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(1) Laudanosine: NMT 0.5%
(2) Other individual impurities: NMT 1.0%
(3) Total Impurities: NMT 3.5%
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0.01%
0.38%
1.3%
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Isomer Ratio
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Trans-Trans Isomer: 5%-6.5%
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5.7%
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Cis-Trans Isomer: 34.5%-38.5%
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36%
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Cis-Cis Isomer: 55%-60%
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58.2%
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Assay
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96%-102%
(C65H82N2O18S2 on anhydrous basis)
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100.2%
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Residue Solvents
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(1) Dichloromethane: NMT 600ppm
(2) Acctonitrile: NMT 410ppm
(3) Ethyl ether: NMT 5000ppm
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Undetected
Undetected
1739ppm
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Result
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Confirms to USP34
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Function of Cisatracurium besylate
Cisatracurium besylate is the latest generation of muscle relaxants. Compared with the main clinical muscle relaxant anesthetics, this product has the characteristics of metabolism through non-hepatic and non-renal pathways and cardiovascular stability. Tracurium is 3 times stronger and has no cardiovascular side effects. Cisatracurium is mainly used for general anesthesia, and can be widely used in tracheal intubation, liver and kidney dysfunction, cardiovascular surgery, and elderly and pediatric patients. Since the drug was first marketed in the UK in 1996, foreign countries have gradually replaced vecuronium and atracurium, becoming the mainstream of clinical muscle relaxants.
At present, the most commonly used muscle relaxants in clinical practice are medium-term non-depolarizing muscle relaxants, such as Cisatracurium besylate, rocuronium bromide, vecuronium bromide, etc., and the three occupy almost the entire muscle relaxant market, reach to over 98%. Among them, cisatracurium besilate has the advantages of rapid onset, no cardiovascular side effects, no accumulation, and a wide range of applications. It is suitable for special patients such as the elderly, children, abnormal heart, liver and kidney function, and ICU patients. This is an ideal muscle relaxant. This variety has a rapid growth rate and has occupied more than 70% of the muscle relaxant market in 2019, and it can be described as a leader in the muscle relaxant market |
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