Application of Karl Fischer moisture analyzer in the pharmaceutical industry

Drugs are a kind of special commodities. The quality of medicines is directly related to people's life and health. Strict quality control during the production of medicines is a reliable measure to ensure the quality of medicines and safe and effective medicine for people. Therefore, medicines The quality consciousness of production enterprises is becoming more and more concentrated, and the requirements for drug quality testing are getting higher and higher, and higher requirements are also put forward for the technical performance of the instruments used for testing.

In the production process of drugs, the moisture content is an important control index. The level of moisture will affect the quality of drugs and also affect the use of drugs. Therefore, strict control over the production and quality control of drugs is required. Check the moisture content in medicines.

There are many ways to determine the moisture content. The most common method used in the pharmaceutical industry today is to determine the moisture content of a sample using the Karl Fischer method. In the pharmaceutical industry to determine the moisture content of a variety of raw materials, intermediates and finished products, due to a variety of test sample status (such as: finished drugs are tablets, suppositories, freeze-dried as well as some active substances and other In the form), the presence of water in the sample to be measured is different. Free water, crystal water, and the drug components contained in the sample to be measured will affect the measurement. Therefore, when determining the moisture content of the drug, it must be based on the physical properties of the drug. Nature and chemical properties, use different solvents and Karl Fischer reagents.

The volumetric Karl Fischer moisture analyzer can realize full-automatic operation. The instrument has high precision, wide measuring range and rapid measurement. The instrument's built-in method can adapt to different measurement needs. The result report shows a complete set of experimental data, including the test date. , test time, test staff, and all other information required by the GLP specification. The volumetric Karl Fischer moisture analyzer fully satisfies the technical requirements of the Karl Fischer method for determining the moisture content of pharmaceuticals in the Pharmacopoeia of the People's Republic of China (2000 edition).