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Atracurium Besylate

Atracurium Besylate

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Atracurium Besylate with good quality
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MP 85-90°C
storage temp.
2-8°C
Solubility H2O: ~27 mg/mL
Skeletal muscle relaxant for anesthesia Atracurium Besilate is a kind of skeletal muscle relaxant used for general anesthesia; it is suitable for the muscle relaxation required in both the treatment of abdominal surgery and endotracheal intubation. Being same with most neuromuscular blocking agent, it can cause the release of histamine, the occurrence of skin flushing, transient hypotension, and occasional bronchospasm.
Combination between atracurium besilate and inhalation anesthetic gases, such as an alkyl halide, isoflurane and halothane may enhance the neuromuscular blocking effects. Combination with aminoglycoside, polypeptide-class antibiotics, lithium salts, and quinidine or procaine mountain amine may enhance its role in nerve blocking. This product is not suitable to be used in combination with depolarizing muscle relaxants such as suxamethonium which is due to that it may cause prolonged complex blocking effect which is difficult to be reversed by anticholinergic enzyme drugs. Patients who are allergic to this drug should be disabled. It needs to be especially careful for applying this drug in patients of myasthenia gravis, neuromuscular disease, and severe electrolyte imbalance, because it can enhance the effects of other non-depolarizing agents. People suffering from severe cardiovascular disease are more sensitive to the atracurium besilate-induced transient hypotension so it is recommended to apply a slow and graded intravenous injection for administration.
Distinguish At room temperature, atracurium besilate is white-like to yellowish crystalline powder; it is hygroscopic, odorless, easily soluble in chloroform or ethanol, soluble in water, but insoluble in ether.
(1) Take about 10 mg of the product, after adding dilute hydrochloric acid for 1ml to dissolve, add diluted potassium iodide testing solution drop wise, which generates a yellow precipitate.
(2) Take this product, add 0.1mol L hydrochloric acid solution for preparing the solution of concentration being 50μg per 1ml; apply spectrophotometry approach (Chinese Pharmacopoeia 2000 edition of Appendix VI A) for determination with a maximum absorption in the 280nm wavelength.
(3) The infrared absorption spectrum of this product should be consistent with the reference standard map.
Examination Color of the solution
Take 100 mg of this product, add 10 ml of water to dissolve it with which the solution should be colorless; if it exhibits some color, compare it with yellow No. 3 colorimetric solution; it should not have a deeper yellow color (Chinese Pharmacopoeia 2000 edition of Appendix IX A first method).
Relative substance
Take a certain amount of this product; add the mobile phase to make a solution of 1mg per 1 mL, as the test solution; take some amount of the accurate standard sample, add the mobile phase for dilution to make a solution of 50 μg per 1 ml as the control solution. Perform according to the specific content and determine under the following chromatographic conditions, take accurately 10 μl of the standard control solution and add into the liquid chromatography; adjust the checking sensitivity and make the height of major component peaks being 20% to 25% of that of full scale; then accurately take 10 μl of the two above solutions and separately inject it into the liquid chromatography, record the test solution chromatograms until reaching 2-fold major component peak retention time. If there exist impure peaks at the chromatogram of the test solution, measure the sum of the amount of every impure peak area; the sum should not be larger than the peak area of the major component of the control solution (5.0%).
Sulfate
Take 1.0 g of this product, add water 30ml to dissolve it, check it according to inspection(Chinese Pharmacopoeia 2000 edition of Appendix VIII B); compare it with the control solution made by 5.0 mL of standard potassium sulfate solution, and should not be thicker (0.05%).
Loss on weight by drying
Take some amount of this product with phosphorus pentoxide as a desiccant, dry under vacuum at 50 °C for 3 hours with the losing weight should not exceed 2.0% (Chinese Pharmacopoeia 2000 edition of Appendix VIII L).
Ignition of residue
Take 1.0 g of this product, check it according to inspection (Chinese Pharmacopoeia 2000 edition of Appendix VIII N), the left residue should not be over 0.1%.
Heavy Metal
Take the residue of ignition and check it according to inspection (Chinese Pharmacopoeia 2000 edition Appendix VIII H method); the heavy metals content should not exceed twenty millionths.
Chemical Properties It is white-like powder; melting point: 85 ~ 90 °C. It will be softened at 60 °C.
1R-cis, 1R’cis type (Cisatracurium Besylate): [96946-42-8]. White solid.
Application 1. It is a kind of non-depolarizing muscle relaxants with the 2.5 times of effect as high as tubocurarine 2.5 times but with a short duration. It is used for a variety of surgical procedures, especially for intubation and caesarean section.
2. It is a skeletal muscle relaxant for general anesthesia.
Usage A neuromuscular blocking agent
ITEMS SPECIFICATIONS
CHARACTERISTICS A WHITE TO  PALE YELLOW POWDER OR FLAKY CRYSTALS HYGROSCOPIC
SOLUBILITY VERY SOLUBLE IN ACETONITRILE AND CHLOROFORM SOLUBLE IN WATER AND PRACTICALLY INSOLUBLE IN ETHER
IDENTIFICATION 1. UV
2. LR
PH 3.5-5.0
APPEARANCE OF SOLUTION CLEAR TO YELLOW STANDARD NO.7
METHYL BENZENESULPHONATE ≤10PPM
TOLUENE ≤890PPM(ICH)
RELATED SUBSTANCES
TOTAL IMPURITIES ≤7.0%
IMPURITY F ≤3.0%
ANY OTHER SECONDARY IMPURITY ≤2.0%
ISOMER RATIO
CIS-CIS 56.0%~60.0%
CIS-TRANS 34.5%~37.5%
TRANS-TRANS 5.0%~6.5%
LOSS ON DRYING ≤3.0%
SULPHATED ASH ≤0.2%
ASSAY 97.0%~103.0%

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