The ability of a pharmaceutical product to retain its chemical, physical, microbiological and biopharmaceutical properties within specified limits throughout its shelf-life. The stability testing of herbal products check the quality of herbal products which varies with the time under the influence of environmental factors, such as temperature, humidity, light, oxygen, moisture, other ingredient or excipient in the dosage form.

1. STABILITY TESTING OF
NATURAL PRODUCTS
BY- DURGASHREE.M.D
M.PHARM, PHARMACOGNOSY
KLE COLLEGE OF PHARMACY
BENGALURU
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2. CONTENTS
• Introduction
• Objectives
• Types of Stability Studies
• Predictable changes in Herbal Product
• Challenges in Stability testing of HMP
• Steps to Overcome Challenges
• Stability Protocol
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3. INTRODUCTION
• The ability of a pharmaceutical product to retain its
chemical, physical, microbiological and biopharmaceutical
properties within specified limits throughout its shelf-life. (1)
• The stability testing of herbal products check the quality of
herbal products which varies with the time under the
influence of environmental factors, such as temperature,
humidity, light, oxygen, moisture, other ingredient or
excipient in the dosage form.
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4. CONT….
• The most important aspect in the evaluation of the
stability study of a product is its storage condition.
• The purpose of a stability testing is to provide proof on
how the quality of the herbal products varies with the
time.
• Based on the climatic conditions only storage conditions
can be determined. (2)
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5. OBJECTIVES
• To provide evidence on how the quality of active
substance varies with time.
• To establish re-test period for active substance.
• To establish shelf life of finished products.
• To evaluate efficacy of drug.
• To develop suitable packing information for drug product.
• To submit stability information for regulatory agencies. (3)
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6. TYPES OF STABILITY TESTING
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7. TYPES OF STABILITY TESTING
1. Physical Stability Study: Appearance , uniformity,
palatability, Dissolution and suspend ability are
maintained.
2. Chemical Stability Study: API should retain its chemical
integrity and potency, so this involves drug assay and
determination of drug degradation
3. Microbial Stability Study: Sterility or resistance to
microbial growth is maintained as per the specific
requirement.
4. Therapeutic Stability Study: There should be no change
in therapeutic effect.
5. Toxicological Stability Study: No Significant increase in
Toxicity should occur. (3)
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8. PREDICTABLE CHANGES IN HERBAL
PRODUCT
 Hydrolysis: Reaction with water takes place results in
degradation of product.
 Oxidation: Due to addition of electro negative atom (o),
Removal of electro positive atom, radicals formation results in
decomposition of natural products.
 Racemization: Racemization is the process in which one
enantiomer of a compound, such as an L-amino acid,
converts to the other enantiomer.
 Geometric isomerization: Products can be change in trans or
cis form. One form may be more therapeutically active.
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9. CONT…
 Polymerization: There is combination of two or more identical
molecule to form much larger & more complex molecule.
 Temperature: The rate of most chemical increase with
increase in temperature. So that “Tropical” area must be
taken in consideration during preparation of the formula of the
herbal substance.
 Moisture: Moisture absorbed on to the surface of solid drug
will often increase the rate of decomposition, if it is
susceptible to the hydrolysis.
 Light: Many type of chemical reaction induced by exposure to
light of high energy. Autoxidation of volatile oil / fixed oil takes
place and substance becomes colored.
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10. CHALLENGES IN STABILITY TESTING OF
HMP
1. Active substances in HMPs consist of complex mixtures of
constituents and in most cases therapeutic effects are
unknown.
2. The situation is further complicated when two or more herbal
substances are combined in a HMP.
3. In combinations of herbal substances in HMPs, they have
similar constituents which gives rise to even more analytical
challenges.
4. In addition, many herbal preparations are known to be
unstable.
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11. STEPS TO OVERCOME CHALLENGES
1.Use of Marker for Herbal medicinal products
 Markers are chemically known compounds, which may or
may not have therapeutic effect, use to calculate the quantity
of herbal medicinal ingredients in herbal medicinal products.
 Source of Marker
a. Monographs and drafts (EDQM Pharmeuropa).
b. Experience, transfer from other plants/constituents.
c. Literature research about known constituents.
d. Scientific research.
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12. CONT…
2.Analytical methods for Herbal products
 The analysis of herbal preparations is mostly done by
 Running high performance liquid chromatography (HPLC)or
 Gas chromatography (GC) and thin layer chromatography (TLC)
methods,
 Quantitative determinations by UV-visible spectroscopy or
combinations of these.
 HPLC and GC methods can be used for identification and purity
testing, as well as the detection of single compounds for assay,
is possible during one analysis.
 LC and GC mass coupling are the also tools for determination
but, they are highly sophisticated and expensive methods. (3)
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13. Stability zones
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16. STABILITY PROTOCOL
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17. Stability Protocol
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23. REFRENCES
1.Annex 5- Guidelines for Stability Testing.
2. Stability Testing of Herbal Products - Anupam Kumar
Sachan and Ashutosh Kumar (Journal of Chemical and
Pharmaceutical Research, 2015, 7(12):511-514 )
3. Stability Testing of Natural Products-
Slideshare(https://www.slideshare.net/SudhindraKini/stabilit
y-testing-of-herbal-natural-products-and-its)
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