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Sinoway Industrial Co.Ltd.
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Product name
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Atracurium Besylate
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CAS No.
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64228-81-5
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Molecular Formula
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C53H72N2O12.2(C6H5O3S)
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Molecular Weight
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257.60
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Quality Standard
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96% up by HPLC, GMP,USP
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Appearance
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White or almost white powder
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COA of Atracurium Besylate
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ITEMS
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SPECIFICATION
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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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≤ 5.0%
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0.6%
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Residue on ignition
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≤ 0.2%
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0.1%
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Methyl benzenesulfonate
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≤ 0.1%
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Undetected
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Toluene
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≤ 890ppm (ICH)
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102ppm
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Chromatographic purity
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(1) Laudanosine: ≤ 0.5%
(2) Other individual impurities: ≤ 1.0%
(3) Total Impurities: ≤ 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: ≤ 600ppm
(2) Acctonitrile: ≤ 410ppm
(3) Ethyl ether: ≤ 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 Atracurium Besylate
Atracurium besylate is a skeletal muscle relaxant for general anesthesia, suitable for the treatment of muscle relaxation for endotracheal intubation and for muscle relaxation required for thoracic and abdominal surgery. Like most neuromuscular blocking agents, it can Causes the release of histamine, skin flushing, transient hypotension, and occasionally bronchospasm. Caution should be used in patients with myasthenia gravis, neuromuscular disease, and severe electrolyte disturbances, as it potentiates the effects of other non-depolarizing agents. People with severe cardiovascular disease are more sensitive to the transient hypotensive reaction of this product, so it is recommended to give slow intravenous injection in divided doses.
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