Soft capsules are a type of packaging method commonly used in pharmaceuticals or health foods. They are capsules made by processing and sealing liquid or liquid solid drugs in a soft capsule material. The soft capsule material is composed ofcapsule gelatinGlycerol or other suitable medicinal excipients are made separately or in combination.

The client is a domestic health product manufacturing enterprise with an annual sales revenue of 18 billion yuan. The company has not only built a high standard GMP production base and passed the quality management system certification of the Standards Association, but also obtained 86 items and successfully declared 32 types of health products to the national food industry. After customer research, it has been shown that using Mettler Toledo's halogensMoisture analyzerThe moisture content of the soft capsule shell determined by HX204 is consistent with the oven method, and the optimized method only takes about 12 minutes to complete the sample determination.

Soft capsule shells are thicker and more elastic than hard capsule shells, with strong plasticity. The components contained in the soft capsule shell are roughly similar to those in the hard capsule shell.

The elasticity of soft capsules depends on the weight ratio between gelatin, dry plasticizer, and water in the capsule shell. The weight of gelatin and plasticizer determines the hardness of the shell, and the most suitable weight ratio is dry plasticizer: dry gelatin=0.4-0.6:1.0, while the ratio of water to dry gelatin is 1:1. When the weight ratio of several plasticizers to gelatin is 0.3:1.0, the shell becomes hard, and when it is 1.8:1, the shell becomes soft.

In summary, soft capsule shells are usually driedRubber ballsThe moisture content of the rubber shell ranges from 7% to 15%. In addition to affecting the hardness of the rubber balls, moisture may also cause changes in the appearance of the storage life, microbial growth of the rubber balls, chronic oil leakage, adhesion, rubber shell rupture, API degradation, and so on.

Like most samples, the oven method can also determine the moisture content of soft capsules, but the disadvantages of the oven method are obvious: it is time-consuming, the process is complex, and a sample needs to be tested multiple times to determine whether it meets the constant weight standard. Due to the above reasons, many customers in the industry default to using rapid methods for sample testing. Use a rapid moisture analyzer.

Although instruments are relatively fast in detection, the vast majority of instruments on the market require users to first determine the detection method. Otherwise, the test results will not only be unfeasible, but also mislead production. It requires users to repeatedly conduct sample testing and compare it with an oven to find suitable measurement parameters. Then the client needs to conduct a series of tests to demonstrate the robustness of the testing method.

This process is very labor-intensive, fortunately the Mettler Toledo HX204 halogen moisture analyzer can provide a more intelligent solution: its built-inAutoMet method developmentThe function not only helps users quickly locate and determine parameters, greatly shortening the method development cycle, but also simplifies verification, allowing users to easily escape from tedious method development.

The Mettler Toledo HX204 halogen moisture analyzer also features a large Chinese color display touch screen, making it easy for users to read and operate the instrument; With a moisture readability of up to 10PPM, users have more confidence in the accuracy of moisture measurement; The user management function eliminates the need for users to worry about external scrutiny, allowing operators and administrators to have their own usernames, passwords, and different operational permissions; The data transmission function facilitates automatic uploading of measurement data to the server in PDF format.

In addition, in the method optimization engineering, researchers have also found that using glass fiber discs can increase the heating area of the sample, ensure volatilization, greatly optimize the drying process, and obtain reproducible measurement results.