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Standards for the extraction of plastic syringes

Carrie Feb 26,2020 Share this post:

Plastic syringes are mainly used for the filling and use of cow mastitis drugs. Qualified products need to undergo rigorous testing. Leachability testing is an important indicator for plastic syringe testing, which mainly includes four experiments: pH change, heavy metals, easy oxides, and nonvolatiles.


plastic syringe


Leachables


Preparation of test solution: Take the product (needle tube) with an internal surface area of 600 cm2 (divided into 5 cm long and 0.3 cm wide pieces), place in a stoppered conical flask, add an appropriate amount of water, shake and wash the small pieces, discard the water, and repeat the operation Twice. After drying at 30 to 40 ° C, immerse in 200ml of water (70 ° C ± 2 ° C) for 24 hours, then take out and 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. Perform the following tests:


1. pH change value

Take 20ml each of water test solution and water blank solution, add 1.0ml of potassium chloride solution (1 → 1000), and measure according to law (General Regulations 0631 of the Second Edition of Veterinary Pharmacopoeia of the People's Republic of China 2015 Edition). Must not exceed 1.0.


2. Heavy metals

Precisely measure 20ml of water for the test solution, add 2ml of acetate buffer solution (pH 3.5), and measure it according to law (the first method of 0821 of the Second Edition of the Veterinary Pharmacopoeia of the People's Republic of China 2015), containing no more than one millionth .


3. Easy oxide

Precisely measure 20ml of water for the test solution, accurately 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, place in a dark place for 5 minutes, and titrate with sodium thiosulfate titration solution (0.01mol / L). When the titration is near the end point, add 5 drops of starch indicator solution, and continue the titration until colorless. Take another water blank solution and operate in the same way. The difference between the two consumption of sodium thiosulfate titration solution (0.01mol / L) should not exceed 1.5ml.


4. Non-volatile matter

Take 50ml each of the test solution and blank solution accurately, and place them in an evaporation dish with constant weight, evaporate to dryness in a water bath, and dry to constant weight at 105 ° C. The difference between the two should not exceed 12.0mg.


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