Residual Moisture Testing of Lyophilized Products
This webinar will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-died products in vials, to foods. Understanding the different techniques, their limitations, and proper execution will result in more accurate and precise moisture results, which translates into better quality products with longer shelf lives.
Why you should attend:
Monitoring and controlling residual moisture in powders, lyophilized solids, foods, etc can be a critical factor in achieving and maintaining quality products throughout their expected shelf life. Improper levels of moisture in products can result in poor powder flow properties, spoilage, polymorph changes, changes in compaction properties, microorganism growth promotion, higher degradation kinetics, and in the case of freeze-dried products, loss of physical structure and changes in reconstitution properties. There are several methods typically employed to determine residual moisture, and the choice of method will be based on the sample tested, the level of residual moisture present, and the accuracy and precision required for testing. Additionally, many of these methods require a skill and knowledge in preparing and testing the samples if accurate results are to be achieved. In fact, in many cases, samples containing very low residual moisture, as in the case with freeze-dried products, accurate results for residual moisture are not achieved simply due to improper sample preparation and handling. Additionally, inaccurate and or imprecise results will be obtained if the correct method for testing residual moisture is not chosen. In addition to covering the various techniques employed for residual moisture testing, this seminar will pay particular attention to choosing the correct technique for a specific application, specific details of sample preparation, sample handling, and data analysis, all of which can affect the final result. Additionally, a high throughput, non-destructive technique will be discussed, which can be used, if applied correctly, for very rapid and accurate testing with 100% sample recovery.
Areas Covered in the Session:
- Thermal properties of formulated products
- How and where residual moisture is trapped in products
- Effects of residual moisture on dried products
- Gravimetric methods for residual moisture testing
- Near infrared spectroscopy method for residual moisture testing
- Volumetric Karl Fischer titration
- CoulometricKark Fischer titration
- Specialized methods of residual moisture testing
- Proper handling techniques for external extraction in sealed vials
Who Will Benefit:
- Choosing the correct residual moisture test for your applications
- Understanding the advantages and disadvantages of the different techniques covered
- Understanding (via a step by step method) the propertechnique for conducting a coulometric Karl Fischer external extraction (including equations)
This webinar will provide valuable assistance to those companies involved in the handling of powders, lyophilized products, solid pharmaceutical dosage forms, and dried foods.
- Quality Control Scientists
- Development Scientists
- Production Management
- Quality Assurance