Detection of Oxidizable Substances in COP Vial Stoppers

Medical rubber stoppers have good drug resistance and sealing properties. They are commonly used sealing fasteners for injection preparations in current pharmaceutical packaging. COP vials used for biological drug packaging use rubber stoppers to increase the sealing properties of the bottles. The quality of rubber stoppers is related to the safety of drugs. How to detect their oxidizable substances?

RTU(ready to use) 2ml COP vial

Oxidizable substances refer to substances that easily react chemically with oxygen under normal conditions. The most common ones are metals that are prone to rust. In the pharmaceutical packaging industry, they generally refer to substances that easily react with oxygen to oxidize, such as organic matter, reducing agents, sulfur, phosphorus, etc. The control of oxidizable substances is of great significance to ensure the quality of drugs in COP materials within the validity period and prevent the precipitated reducing substances from reacting chemically with drugs, affecting the efficacy and safety of drugs.

In the standard "Halogenated Butyl Rubber Stoppers for Sterile Powders for Injection YBB00052002", the method for detecting oxidizable substances is as follows: accurately measure 20 ml of the test solution, accurately add 20 ml of 0.002 mol/L potassium permanganate solution and 2 ml of dilute sulfuric acid, boil for three minutes, cool rapidly, add 0.1 g of potassium iodide, use sulfur to replace sodium sulfide titration solution (0.01 mol/L) and titrate to light brown, then add 5 ml of starch indicator solution and titrate to colorless. Take another blank control solution and operate in the same way. The difference in the consumption of the two titration solutions shall not exceed 7.0 ml.

sterile vial in tray

As the main packaging for high-value-added drugs such as biological drugs, the detection of oxidizable substances in COP vials cannot be ignored. This is also an important indicator for testing the quality of drug packaging. When selecting drug packaging, pharmaceutical companies should comprehensively evaluate the overall performance of the packaging and select high-quality packaging to ensure drug safety.