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
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 3rd ,6th , 9th , 12th , 18th ,
24th , 36th month.
Intermediate testing are conduct 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 3rd
and 6th month.

7. Testing Frequency
Stability
Study
Storage Condition Testing Frequency
Accelerated 40 ± 2°C & 75 ± 5% RH 0,1,2,3 &6
Intermediat
e
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

12. THANKS!
Do you have any questions?
easyconceptkaushal@gmail.com
+91 9546688666