Guidelines for stability testing of herbal drugs

Drug stability is defined as the ability of the pharmaceutical dosage form to maintain the
Physical, chemical, therapeutic and microbiological properties
during the time of storage and usage by the patient.
Well being of the patient & manufacturer by ensuring product quality. For selection or adequate formulation, determination of shelf-life and storage conditions. Preparation and substantiation of the claimed shelf life for the registration dossier. To provide evidence on how quality of drug variance with time under influence of environment

1. Quality Control & Standardization Of Herbals Guidelines For Stability Testing Of Herbal Drugs By Kaushal Kumar

2. TABLE OF CONTENTS 01 02 03 04 Introduction Need For Stability Preparation Reason For Stability

3. Drug stability is defined as the ability of the pharmaceutical dosage form to maintain the Physical, chemical, therapeutic and microbiological properties during the time of storage and usage by the patient. INTRODUCTION

4. ☺ Well being of the patient & manufacturer by ensuring product quality. ☺ For selection od adequate formulation, determination of shelf-life and storage conditions. ☺ Preparation and substantiation of the claimed shelf life for the registration dossier. ☺ To provide evidence on how quality of drug variance with time under influence of environment. Need For Stability Studies

5. Herbal products are complex in nature due to high number of constituents of different chemical classes . Classified entirely on basis of the API . EMEA, has subdivided herbal preparation's into three categories based on the active constituents in the product. Herbal Drugs & Preparations Quantified Extract Other Extract Standard Extract

6. Reason For Instability Moisture & Hydrolysis Reaction with water leads to degradation of compounds Oxidation Geometric Addition of oxygen, radical formation & decomposition of product Trans & cis form, one form may be more therapeutically active Polymerization Combination of one or more mol. Forming largest molecules Temperature Chemical changes increase with increase in temperature Light Chemical changes due to exposure to light auto oxidation of volatile oil

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