general stability testing guideline

The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity & light.


Herbal Medicinal Products have a number of characteristics that clearly differentiate them from chemically defined medicinal products & therefore specific stability guidelines needed to be established.
In accelerated stability testing the samples are subjected to stress, refrigerated after stressing, & then assayed simultaneously.

1. Quality Control & Standardization Of Herbals General Stability Testing Of Guidelines By Kaushal Kumar

2. TABLE OF CONTENTS 01 02 03 04 Introduction Climate Testing Method Protocol

3. The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors such as temperature , humidity & light . Herbal Medicinal Products have a number of characteristics that clearly differentiate them from chemically defined medicinal products & therefore specific stability guidelines needed to be established. INTRODUCTION

4. To select adequate formulations To determine shelf life and storage conditions To substantiate the claimed shelf life To verify that no changes have been introduced in formulation that adversely affects the stability. Objectives

5. Climate Zones Zone Type of Climate Countries Long Term Testing Condition Zone I Temperate Zone UK, US Northern Europe 21°C / 45%RH Zone II Subtropical Zone Japan, S. Europe 25°C / 60%RH Zone III Hot Dry Zone Iraq, India 30°C / 35%RH Zone IV Hot Humid / Tropical Zone Iran, Egypt 30°C / 65%RH Zone IV b Higher Humidity Brazil, Singapore 30°C / 75%RH

6. R Stability Testing Methods REALTIME ACCELERATED INTERMEDIATE STRESS TEST Real time stability testing is normally performed for longer duration of the test period. 25-30°C & 35-75% RH (Depending on climate zone) for 3 rd ,6 th , 9 th , 12 th , 18 th , 24 th , 36 th month. Intermediate testing are c onduct when accelerated studies fail . At 25°C for longer duration of time. Stress testing includes effect of temperature i.e. above 40°C and ≥ 75% RH In accelerated stability testing the samples are subjected to stress, refrigerated after stressing, & then assayed simultaneously . Product subjected to high temperature , humidity, light, etc 40°C / 45% RH at 3 rd and 6 th month.

7. Testing Frequency Stability Study Storage Condition Testing Frequency Accelerated 40 ± 2°C & 75 ± 5% RH 0,1,2,3 &6 Intermediate 30 ± 2°C & 65 ± 5% RH 0,3,6,9,12,18,24 & 36 Long Term 25 ± 2°C & 60 ± 5% RH 0,3,6,9,12,18,22,24,26,36,48 &60

8. Active substance in HMPs consist of complex mixtures of constituents & most of markers & their therapeutic effects are unknown ☺ The guidelines on stability testing of drug substance and related finished products were established for chemically defined substance . Herbal drug substances should only be tested at 25°C / 60 % RH with no requirement for accelerated / intermediate testing . Many herbal compounds are unstable hence, a set of test criteria including qualitative & quantitative parameters has been recognised as quality indicating parameters. In combined formulations different substance having similar constituents give rise to analytical challenges, Different studies are conducted during 1 year for such changes. ☻ ♥ Challenges in Stability Testing

9. Testing Frequency Formal Stability Studies Conducted on at least three primary batches. Stability performed on each individual strength & container size till bracketing Ongoing Stability Studies All product have to be tested at least one batch a year. Wherever appropriate, bulk products are also to be tested. Applies to every dosages & packaging size & type. Long Term Stability On at least three batches performed under natural conditions.

10. Parameter Organoleptic Analysis ☺ Color ☺ Odor ☺ Taste Physiochemical Analysis ☻ Determination of pH ☻ Ash Value ☻ Extractive Value ☻ Moisture Content Quantitative Analysis ◘ Specific Biomarker ◘ Fingerprint Profile ◘ Reference to Comparable Herbal Formulation ◘ Group of Compounds (Total Alkaloid, Phenolic, Glycoside content) Microbiological Analysis ◙ Total Microbial Count

11. Protocols For Stability Testing Selection of Batches & Samples Test Attributes Analytical Procedures Acceptance Criteria Storage Condition & Duration Testing Frequency Sampling Plan Container Closure System Evaluation Labelling

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