Source: Link Testing Instruments Co.,Ltd.
There are many types and forms of pharmaceutical products, most of which are sensitive to oxygen, easily oxidized and deteriorated, discolored, and smelly, etc., which not only affect the curative effect of the product, but the toxic and harmful substances produced by oxidation can even endanger life. Medicines with ingredients such as calcium salts tend to absorb carbon dioxide to form carbonates. In order to reduce the amount of oxygen and carbon dioxide that medicines are exposed to as much as possible, oxygen and carbon dioxide sensitive medicines are usually packaged in the form of vacuuming and filling in inert gases such as nitrogen to reduce the content of oxygen and carbon dioxide in the packaging. However, vacuum packaging and nitrogen-filled packaging cannot completely remove or replace the gas inside the package, and the packaging material has a certain degree of air permeability, so there will always be a certain amount of oxygen and carbon dioxide left in the package, and the content of gas components is not constant. It will increase with the extension of drug storage time. Monitoring the residual oxygen and carbon dioxide content in the packaging is not only one of the effective means to ensure the good quality of drugs, but also a basis for determining the shelf life.
Test principle and Instrument introduction
At present, there is no domestic method standard specifically for the detection of gas content in packaging. The detection standard referred to in this article is GB/T 6285-2003 "Electrochemical Method for the Determination of Trace Oxygen in Gases".
The test equipment used in this test is the LTDK-190 headspace gas analyzer independently developed and produced by Link Testing Instruments Co., Ltd.
Test principle: The gas inside the package flows through the oxygen sensor and carbon dioxide sensor equipped with the instrument through the sampling device, so as to measure the oxygen content and carbon dioxide content in the gas in the package. The sampling device of the instrument includes a sampling needle and a gas collection device. For pharmaceutical products packed with nitrogen, the gases in the packaging are mainly nitrogen, oxygen and carbon dioxide. By testing the content of oxygen and carbon dioxide, the nitrogen content can be obtained.
Test sample and test process
Test sample: A certain brand of injection packaging ampoule was used as the test sample.
Experimental procedure:
1. Setting parameters: Set the test parameters such as sampling time and analysis time on the instrument control panel.
2. Collect gas: put 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, and the test starts. The instrument absorbs the sample gas in the collection device and analyzes it. After the test, the device automatically displays the measured gas.
Test results, namely oxygen content, 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 content of oxygen and carbon dioxide in the packaging is an important factor affecting the quality of medicines. Among them, the amount of residual oxygen is one of the basic requirements of GMP for the inert gas packaging of sterile medicines. This paper uses the headspace gas analysis independently developed and produced by Link Testing to test the packaging of injection solutions. The oxygen and carbon dioxide content in the ampoule is used to calculate the nitrogen content, the whole test process is simple, the instrument is easy to operate, and the test result is accurate and reliable.
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