A drug component (e.g., excipient or active pharmaceutical ingredient) or a final drug product (e.g., tablet or capsule) may contain water within its contents, either bound as a hydrate within the crystalline structure or adsorbed onto the material surface. Further, water content may change throughout the shelf-life of the drug component (or drug product) and potentially affect the quality, efficacy, or stability of the material. Therefore, it is important to be able to monitor and control the content of water within the drug component (or drug product).

USP 〈921〉 Water Determination describes three different types of test methods that are common for the determination of water within pharmaceutical materials. These test methods include: Method I Karl Fischer (“KF”) titration, Method II azeotropic distillation with toluene, and Method III gravimetric analysis (i.e., loss on drying). Karl Fischer titration is the most widely used of these techniques for the determination of water within pharmaceutical materials. The methodology is highly specific for water, sample size requirements are often small (milligrams), and detection limits are low (down to 1 ppm). By comparison…….

Download our PDF to learn more about compliant water determination methodologies to support your drug development efforts.

Why Choose Parsolex?

Parsolex offers analytical services to our clients to support water determination testing by Karl Fischer titration. Parsolex is committed to fully understanding our clients’ requirements and to delivering each project on agreed upon timelines with high-quality deliverables. Parsolex possesses in-depth experience with the successful execution of water determination testing by Karl Fischer titration per current regulatory guidance.

Contact us today to discuss how we can support your Water Determination testing needs.