As per PCI Syllabus

1. Stability Testing of Herbal
Drugs
S.Selvadurai.,M.Pharm.,MBA.,
Associate Professor
Department of Pharmacognosy

3. What is Stability?
“the capacity of a drug to remain
within established speifications limits
to maintain its identity, quality &
purity throughout the retest or
expiration dating periods”

4. CONCEPT OF STABILITY
Stability is the capacity of a specific formulation in a
particular container/closure system to remain within its
prescribed limits like
Physical Chemical Microbiological
Therapeutic
Specifications

5. ADVANTAGES
Help in determination of shelf life and
storage conditions.
Help in selection of suitable formulation,
excipients and container closure
systems for a product.
Well being of the patient and
manufacture by ensuring the good
product quality.
Enhance patient confidence in herbal
drugs and improve compliance.

6. TYPES OF STABILITY STUDY AS PER USP
S.No Type of Stability
Condition to be maintained throughout the
shelf life of drug product
01 Physical
The original physical properties, namely,
appearance, uniformity, dissolution &
suspendability are maintained.
02 Chemical
Each & Every active ingredient retains its
chemical integrity as well as potency
specified on lable, within the specified
limits.
03 Microbiological
Sterility or resistance to microbial growth
is maintained as per the specified
requirements
04 Therapeutic The therapeutic effect remains unaltered
05 Toxicological No valid increase in toxicity occurs

7. SPECIFICATIONS CRITERIA FOR HERBAL DRUGS
Specifications
Botanical
Characters
Macro, Micro,
Phyto, toxic
constituents
Biological/Geogr
aphical
Pre/Post
harvest
chemical
treatments
Profile &
stability of the
constituents

8. DIFFERENT STABILITY TESTING METHOD
Real time testing
Accelerated testing
Intermediate testing
Stress testing
Forced degradation testing
01
02
03
04
05

9. PROTOCOL FOR STABILITY TESTING
01 • Selection of bacterial and samples
02 • Test Selection
03 • Analytical Procedure
04 • Acceptance Criteria
05 • Storage Conditions
06 • Testing frequency
07 • Storage period
08 • Sampling Plan
09 • Container closure system
10 • Evaluation
11 • Statement, Labeling

10. RECOMMENDED STABILITY TEST FOR DIFFERENT HERBAL
DOSAGE FORMS ACCORDING TO WHO
01
Decoctions,
glycerites,
aceterites,
Oxymels
Changing in
Colour, Odour,
taste, clarity,
Specific gravity,
pH, Viscosity etc..
02 Tablets
Changing in Color,
pH, hardness,
friability, swelling,
Microbial
contamination etc

11. 03 Capsules
Change in Colour, pH,
total extractive,
brittleness, hardening or
softening of shell, etc…
04
Alcoholic
beverages,
tinctures Extracts
Clarity, pH, Specific
gravity, alcohol
content, total solid
residue etc.,

12. 05
Teas &
powders
Change in Odour,
Moisture content, pH,
total water extractive,
formation of hard
mass, etc..
06
Ointments
& Balms
Change in
color,odour,
homogeneity, pH,
consistency,
grittiness etc..

13. 07 Oils
Rancidity, Change
in color, odour,
pH, microbial
contamination and
toxicity.
08
Pastes &
creams
Change in color, odour,
homogeneity, pH,
Consistency,Phytochemic
al constituents etc…

14. 09 Soaps
Chang in color,
odour,
homogeneity, pH,
toxicity/skin
sensitivity tests.
10 Suppositories
Softening,
hardening, or
drying, dissolution

15. FACTORS AFFECTING STABILITY OF NATURAL
MEDICINES

16. ISSUES RELATED TO STABILITY OF HERBAL DRUGS
Issues related to
stability of herbal drugs
Physical
Instability
Processing
Environment
Chemical
Instability
Complexity
Drug
Interactions