Prefilled syringes are mainly used for the filling and […]
Prefilled syringes are mainly used for the filling and use of drugs. Qualified products need to undergo rigorous testing. Dissolution testing is an important indicator of prefilled syringe testing. It mainly includes four tests for pH change, heavy metals, easy oxides and nonvolatiles.
Preparation of test solution for dissolution of prefilled syringe: Take this product (needle) with an inner surface area of 600cm2 (split into small pieces of 5cm in length and 0.3cm in width), place them in a conical flask with stopper, add appropriate amount of water, and shake to wash the small pieces. Discard the water and 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 to the original volume as the test solution, and use the same batch of water as the blank solution , Carry out the following tests:
1. pH change value
Take 20ml each of the water test solution and the water blank solution, add 1.0ml potassium chloride solution (1→1000) respectively, and determine according to law, the difference between the two pH values shall not exceed 1.0.
2. Heavy metals
Accurately measure 20ml of the test solution of water, add 2ml of acetate buffer (pH 3.5), and determine according to law, the content of heavy metals shall not exceed one millionth.
3. Easy to oxide
Accurately measure 20ml of water for 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 potassium iodide, place it in a dark place for 5 minutes, and titrate with sodium thiosulfate titrant (0.01mol/L). When the titration reaches the end point, add 5 drops of starch indicator solution and continue the titration until it is colorless. In addition, take the water blank solution and operate in the same way. The difference between the two consumption of sodium thiosulfate titrant (0.01mol/L) shall not exceed 1.5ml.
4. Non-volatile matter
Precisely measure 50ml each of the water test solution and the blank solution, put them in an evaporating dish with constant weight, evaporate in a water bath, and dry to constant weight at 105°C. The difference between the two should not exceed 12.0mg.
https://www.syringeassemblymachines.com/
