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Pyrogen Inspection of Pharmaceutical Packaging

Carrie Dec 25,2019 Share this post:

The pyrogen inspection method for pharmaceutical packaging injects the test solution intravenously into rabbits, and observes the temperature rise of the rabbits within a specified time to determine whether the limit of the pyrogen contained in the test product meets the requirements.

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Preparation of test solution: The preparation process is performed according to aseptic operation method. Rinse the test sample with purified water and blot dry with filter paper. Unless otherwise specified, cut into 0.5cmX3cm strips without counting the increase in surface area due to segmentation. For potential extraction performance differences between intact and cut surfaces, if necessary, to maintain the integrity of the test product. Unless otherwise specified, the test product is placed in an autoclave at 115 degrees for 30 minutes. Prepare test solution according to the following table. Test solution should be used within 2h after preparation.

Inspection method Take the test solution and test and judge the results according to the pyrogen inspection method (General Regulation 1142 of the Fourth Part of Chinese Pharmacopoeia), which should meet the requirements.

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