Herbal QC: Analytical Methods

Having a sound quality control (QC) system in place and meeting the documentation standards for regulatory compliance can mean gaining familiarity with analytical testing. If you've seen the acronyms TLC, HPLC, or GC on an herbal Certificate of Analysis, but aren't sure exactly what they mean, you aren't alone! In this class, we'll go through some of the test methods commonly used to establish identity, purity, potency, and safety of botanical material. The focus will be more on the principles and the process behind the testing rather than specific regulatory requirements. While some of the material will be technical in nature, the class is intended for an audience of non-scientists.

Audience

Laboratory technicians, quality assurance personnel, quality control personnel, herbal product or dietary supplement small business owner/operator

Topics Include

21 CFR Part 111
Designing a testing plan
Setting specifications
Selecting an analysis method
Reference methods
Method fitness for purpose
Botanical identity methods
Testing for impurities
Constituent analysis
Questions to ask your contract lab

Learning Objectives

Recognize the importance of laboratory testing for complying with current Good Manufacturing Practices.
Explore analytical methods to establish identity, purity, quality, and strength of herbal material.
Examine the scope of analytical testing of raw herbal material.
Identify sources for reference methods and material specifications.
Interpret a Certificate of Analysis or laboratory report.