Course Description:USP General Chapter Total Organic Carbon (TOC) has been official since USP 23 (1996), and it has been adopted by other pharmacopoeias as the primary method for the determination of organic impurities in Purified Water and Water for Injection. USP Total Organic Carbon is one of the two primary chemical limit tests (USP Water Conductivity is the other for ionic impurities) to determine that there is sufficient control/reduction of chemicals in the water purification system. This webinar will explain the purpose of this test, the instrumentation requirements, calibration requirements, the value of on-line and off-line measurements, and the test limit requirements for various pharmaceutical waters, including the changes introduced in 2021 for sterile packaged waters.
Upon completion of this course, you will be able to:
- Identify the basic principles of the TOC method.
- Identify where TOC impurities come from and how they are controlled.
- List the instrumentation requirements of .
- Identify the differences between on-line and off-line measurements and requirements.
- Describe the test limits for various bulk and sterile waters for USP and their comparison with other pharmacopoeias
Who should participate:
- Analytical chemists
- QA/QC managers
- Compliance managers
- Water system engineers and owners
- Lab managers
- Production managers
- Regulatory affairs specialists