Nov. 17, 2020
Dissolution test polypropylene bottle:
Preparation of test solution: Take the internal surface area of the flat part of this product 600cm2 (split into pieces of 5cm long and 0.3cm wide), set add appropriate amount of water to the conical flask, shake and wash the small pieces, discard the water, and repeat the operation twice. After drying at 30～40℃, use water (70℃±2℃), After soaking in 200ml for 24 hours, take it out and let it cool to room temperature, use the same batch of test solvent to make up the original volume as the test solution, and use the same batch of water as a blank.
Liquid, perform the following tests:
6.9.1 pH change
Take 20ml each of the test solution and the water blank solution, add 1.0ml of potassium chloride solution (1→1000) respectively, according to the pH measurement method. The General Principles of Veterinary Pharmacopoeia of the People’s Republic of China 2015 General Regulations for the Second Department (0631) determined that the difference between the two does not exceed 1.0.
6.9.2 Heavy metals
Accurately take 20ml of water for the test solution, add 2ml of acetate buffer (pH 3.5), check according to law ("Veterinary Pharmacopoeia of the People's Republic of China") The 2015 edition of the General Principles of the Second Department (0821, Act 1), containing heavy metals shall not exceed one part per million.
6.9.3 Easy oxide
Accurately take 20ml of water for the test solution, add 20ml of potassium permanganate titration solution (0.002mol/L) and 1ml of dilute sulfuric acid, and boil for 3 minutes. Cool quickly. Add 0.1g of potassium iodide, place it in the dark for 5 minutes, titrate with sodium thiosulfate titration solution (0.01mol/L), when the titration reaches the end, then add 5 drops of starch indicator solution and continue titration until colorless. Take another water blank solution and operate in the same way, both consume sodium thiosulfate titration solution
(0.01mol/L) The difference should not exceed 1.5ml.
6.9.4 Non-volatile matter
Accurately take 50ml each of the test solution and blank solution into a constant weight evaporating dish, evaporate in a water bath, dry at 105℃ for 2 hours, and cool. After precise determination, the difference between the residue of non-volatile water and the residue of its blank solution should not exceed 12.0mg.
Take water for the test solution and check it according to the law ("General Rules of the People's Republic of China Veterinary Pharmacopoeia 2015" Part Two), the solution should be clear, if it is cloudy, compared with No. 2 turbidity standard solution, it shall not be thicker.
Take the appropriate amount of water for the test solution, according to the ultraviolet-visible spectrophotometry ("General Regulations of the People's Republic of China Veterinary Pharmacopoeia 2015" Part Two 0401). It is determined that the maximum absorbance in the wavelength range of 220～360nm shall not exceed 0.10.
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