This workshop will build on your knowledge of HPTLC and its applicability to the analysis of various articles, with an emphasis on botanical materials, including raw materials, extracts and finished products. The workshop will strengthen attendees' skills and confidence to meet the sometimes burdensome and complicated requirements of establishing product specification and ingredient identity as required under the dietary supplement current good manufacturing practice (cGMP) (21 CFR 111).
The workshops will cover:
- HPTLC analytical process and its parameters in a cGMP compliant environment
- Getting the most out of your HPTLC instrument
- Elements of HPTLC method development and validation
- Elements of transfer validation
- Qualitative and quantitative aspects of HPTLC analysis
- Quality of botanicals - a moving target
- Pragmatic approaches to quality
- Passing / failing samples based on HPTLC fingerprints
- Quality of finished products, setting specification, and stability issues
- Investigate participants' samples
Discussions will be accompanied by:
- Extensive hands-on laboratory sessions
- Case studies
Supplement cGMP regulations require that QC/QA personnel be adequately trained in dietary ingredient testing. Each participant shall receive a Certificate of Completion to document attendance and training.
Who should attend
Anyone with experience in utilizing HPTLC as a tool for assessment of various articles, with an emphasis on botanical materials, including QC/QA personnel, laboratory personnel, regulatory compliance personnel, natural products researchers, dietary supplement companies looking for economical means to comply with the cGMP requirements regarding establishing identity and quality.
Eike Reich, Ph.D.
Director of Laboratory
Maged Sharaf, Ph.D.
Chief Science Officer