There are many types and forms of pharmaceutical products. Most products are sensitive to oxygen and are easily oxidized and deteriorated, causing discoloration and odor. This not only affects the efficacy of the product, but the toxic and harmful substances produced by oxidation may even endanger life. Drugs containing hydroxides, calcium salts and other ingredients are easy to absorb carbon dioxide to form carbonates. In order to minimize the amount of oxygen and carbon dioxide that the drugs are exposed to, oxygen- and carbon dioxide-sensitive drugs are usually packaged in the form of vacuuming and filling with inert gases such as nitrogen to reduce the oxygen and carbon dioxide content in the package. However, vacuum packaging and nitrogen-filled packaging cannot completely remove or replace the gas inside the package, and the packaging material has a certain air permeability. Therefore, a certain amount of oxygen and carbon dioxide will always remain in the package, and the content of the gas components is not constant, but will increase with the extension of the storage time of the drug. Monitoring the residual oxygen and carbon dioxide content in the package is not only one of the effective means to ensure the good quality of the drug, but also can be used as a basis for determining the shelf life.
Test principle and equipment introduction
At present, there is no method standard specifically for the detection of gas content inside packaging in China. The test standard temporarily referred to in this article is GB/T 6285-2003 "Electrochemical method for the determination of trace oxygen in gas".
(PS: At present, the latest domestic packaging headspace detection standard GB/T 41682-2022 "Determination of headspace gas content in food plastic packaging containers Sensor method" has been officially implemented and can be used for reference!)
The test equipment used in this test is LTDK-190 headspace gas analyzer independently developed and produced by Link Testing Instruments Co.,Ltd.
Test principle: The gas inside the package is made to flow through the oxygen sensor and carbon dioxide sensor configured by the equipment through the sampling part, so as to measure the oxygen content and carbon dioxide content in the gas inside the package. The sampling part of the equipment includes a sampling needle and a gas collection device. For medical products in nitrogen-filled packaging, the gases in the packaging are mainly nitrogen, oxygen and carbon dioxide. The nitrogen content can be obtained by testing the content of oxygen and carbon dioxide.
Test sample and test process Test sample: A certain brand of ampoule for injection packaging is used as the test sample.
Test process:
1. Set parameters: Set the test parameters such as sampling time and analysis time on the device control panel.
2. Collect gas: Place the ampoule sample to be tested in the gas collection device, open the sample carefully, and the gas in the bottle will be collected in the gas collection device.
3. Test: Carefully insert the sampling needle into the gas collection device, click the test button, the test starts, the instrument absorbs the sample gas in the collection device and analyzes it, and after the test, the device automatically displays the test results, that is, the oxygen content and carbon dioxide content.
Test results and analysis: The oxygen content in the ampoule sample tested this time is 0.96%, and the carbon dioxide content is 0.08%. If the gas filled in the sample is high-purity nitrogen, the nitrogen content in the bottle is 98.96%.
The oxygen and carbon dioxide content in the package is an important factor affecting the quality of the drug, among which the residual oxygen content is one of the basic requirements of GMP for the inert gas packaging of sterile drugs.
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