- Sep 30, 2017 -
Color of the solution
Take 100 mg of Atracurium besylate CAS:64228-81-5, 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).
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%).
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%.
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.