The infuser is mainly used for the filling and use of m […]
The infuser is mainly used for the filling and use of medicines. Qualified products need to undergo rigorous testing. The dissolution test is an important indicator of the perfusion device. It mainly includes four experiments: pH change, heavy metals, easy oxides and non-volatile matter.
Preparation of test solution for dissolution: Take the inner surface area of this product (needle) 600cm2 (split into pieces of 5cm in length and 0.3cm in width), place in a conical flask with a stopper, add appropriate amount of water, shake and wash the small pieces, discard the water, Repeat the operation twice. After drying at 30～40℃, soak in 200ml of water (70℃±2℃) 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 the blank solution , Conduct the following tests:
1. pH change value
Take 20ml each of the test solution and the water blank solution, add 1.0ml of potassium chloride solution (1→1000) respectively, and measure according to the law. The difference between the two pH values must not exceed 1.0.
2. Heavy metals
Accurately take 20ml of water for the test solution, add 2ml of acetate buffer (pH 3.5), and determine according to the law that the content of heavy metals should not exceed one part per million.
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, boil for 3 minutes, and quickly cool to room temperature. Add 0.1g of potassium iodide and place it in the dark for 5 minutes. Titrate with sodium thiosulfate titration solution (0.01mol/L). When titrating to the near end point, add 5 drops of starch indicator solution and continue to titrate to colorless. Take the water blank solution in the same way, and the difference between the consumption of sodium thiosulfate titration solution (0.01mol/L) should not exceed 1.5ml.
4. Non-volatile matter
Accurately take 50ml each of the test solution and the blank solution, put them in an evaporating dish of constant weight, evaporate to dryness in a water bath, and dry to constant weight at 105 ℃, the difference between the two should not exceed 12.0mg.
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