STANDARDISATION OF HERBAL EXTRACTS ZHARI ISMAIL PhD PUSAT - PowerPoint PPT Presentation

STANDARDISATION OF HERBAL EXTRACTS ZHARI ISMAIL PhD PUSAT PENGAJIAN SAINS FARMASI UNIVERSITI SAINS MALAYSIA National Regulatory Conference 2013, 7-9 May, Kuala Lumpur

CONTENTS • INTRODUCTION • WHAT & WHY OF STANDARDISATION • HOW TO STANDARDISED • WHEN, WHERE & WHO • ISSUES & PROBLEMS • CONCLUSION National Regulatory Conference 2013, 7-9 May, KL

Introduction • Label accuracy of herbal products • Authenticity • Quality • Safety • Efficacy issues • Quality of life or wellness products National Regulatory Conference 2013, 7-9 8 May 2013 3 May, KL

What & why standardised • Consistently consistent product • Reproducibility • Guaranteed potent/active • Value added • Prerequisite for preclinical & clinical studies National Regulatory Conference 2013, 7-9 8 May 2013 4 May, KL

How to standardise • Chemically • Biologically • Physicochemical parameters • Spectroscopically • Chromatographically • Metabolomics • Chemometrics National Regulatory Conference 2013, 7-9 8 May 2013 5 May, KL

When, where and who • From seeds to shelve • GACP, GLP, GMP • Trained technical personnel • Registered professionals National Regulatory Conference 2013, 7-9 8 May 2013 6 May, KL

Issues & problems • Standard materials • Collection of reference standards • Marker compounds • Official methods • Technical Monographs National Regulatory Conference 2013, 7-9 8 May 2013 7 May, KL

Conclusion • Garbage in garbage out • Must have rather than nice to have • Transformation of products • High value herbs • Fulfilling global needs National Regulatory Conference 2013, 7-9 8 May 2013 8 May, KL

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