In the effervescent tube tube test project, the dissolution test is a very important physical and chemical performance test. Among them, n-hexane is an important indicator that is highly valued by major pharmaceutical companies. It is mainly used to simulate the state of pharmaceutical packaging materials and containers. A method for detecting the quality of a product by testing the results of various solvent elution tests. A method for detecting the quality of a product by testing the results of various solvent elution tests. The solvents commonly used in the national standard drug packaging material dissolution test are water, 65% ethanol and n-hexane.
The cover and tube are separately tested according to the overall material of the effervescent tube. The most important one in the test of n-hexane dissolution is the detection of non-volatiles. The evaporation residue of plastics of different materials is different. Among them, the risk of non-volatile non-volatiles of polyethylene (PE) is the highest, which should be combined with the actual situation. The uncertainty of the measurement of the non-volatile matter of the oral solid pharmaceutical low-density polyethylene moisture-proof combination cap and the oral solid pharmaceutical polypropylene bottle was evaluated.
Take a flat surface area of 600cm2 (divided into 5cm long and 0.3cm wide), place it in a conical flask, add some water, shake the small pieces, discard the water, and repeat the operation once. After drying at 30 to 40 ° C, it was immersed in n-hexane (58 ± 2) ° C 200 mL for 24 hours, then taken out and allowed to cool to room temperature, and then replenished to the original volume as a leachate with the same batch of test solvent, and the same batch of n-hexane was used as a blank solution. Separately measure 50 mL of each of the n-hexane leaching solution and the blank solution, place them in a constant weight evaporating dish, evaporate in a water bath, and dry at 105 ° C for 2 h. After cooling, accurately weigh.
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