Stability testing of dosage forms is an important aspect of pharmaceutical development and manufacturing. It involves evaluating the physical, chemical, and microbiological attributes of a dosage form over a specific period of time under various storage conditions. The purpose of stability testing is to ensure the efficacy, quality and safety of the drug throughout its shelf life. . SCOPE OF STABILITY TESTING Provide evidence as to how the quality of drug product varies with time. Determine recommended storage conditions. Establish shelf life for the drug product. Establish quality of a drug product or substance . Determine container and closure system suitability .

1. Stability
Testing
Presented by – MANSHI RANA
AMITY UNIVERSITY HARYANA
M.Pharma 1st year
(Pharmaceutics)

2. CONTENT
• INTRODUCTION
• SCOPE
• IMPORTANCE
• FACTORS EFFECTING
• TYPES
• METHODS
• REGULATORY REQUIREMENTS

3. INTRODUCTION
• Stability testing of dosage forms is an important aspect of
pharmaceutical development and manufacturing. It involves
evaluating the physical, chemical, and microbiological attributes of a
dosage form over a specific period of time under various storage
conditions.
• The purpose of stability testing is to ensure the efficacy, quality and
safety of the drug throughout its shelf life.
.

4. • The time from the date of manufacture of the formulation until its
chemical and therapeutic activity is maintained to a predetermined
level of labeled potency and,its physical characteristic have not
changed.
• Shelf life – the time required for a drug to decay to 90% of its original
concentration.

5. SCOPE OF STABILITY TESTING
• Provide evidence as to how the quality of drug product varies with
time.
• Determine recommended storage conditions.
• Establish shelf life for the drug product.
• Establish quality of a drug product or substance .
• Determine container and closure system suitability .

6. IMPORTANCE OF STABILITY TESTING
Assurance to patient that drug is safe.
legal requirement to provide data.to protect the reputation of the
manufacturer.to provide a database.
To determine shelf life and storage conditions.
To verify that no changes have been introduced in the formulation or
manufacturing process that can adversely affect the stability of the
product.

7. FACTORS EFFECTING DRUG STABILITY
Primary factors effecting drug stability are:
PH, temperature, moisture, humidity, light, storage closure and
containers oxygen
major factors effecting drug stability are:
size (suspension and emulsion), PH ,additives and molecular binding
and diffusion of drugs and excipients

8. TOXICOLOGIC
STABILITY
PHYSICAL
STABILITY
MICROBIOLOGIC
AL STABILITY
THEARAPEUTICAL
STABILITY
CHEMICAL
STABILITY
TYPES

9. • 1. Chemical Stability: It refers to the ability of a drug to maintain its
chemical integrity and potency over time. Factors such as temperature,
humidity, pH, and light exposure can affect the chemical stability of a drug.
• 2. Physical Stability: It relates to the physical properties of a drug,
including its appearance, color, odor, and physical state (solid, liquid, or
gas). Physical stability ensures that the drug remains unchanged in terms of
its physical characteristics.
• 3. Microbiological Stability: It refers to the ability of a drug to resist
microbial contamination and maintain its sterility. This type of stability is
crucial for injectable drugs and other sterile preparations.
• 4. Therapeutic Stability: It relates to the ability of a drug to retain its
therapeutic activity and efficacy over time. Factors such as degradation,
oxidation, or interaction with other substances can impact the therapeutic
stability of a drug.
• 5. Toxicologic Stability : No significant increase in toxicity occurs .

10. METHODS OF STABILITY TESTING
Real-time stability testing: This method involves storing the product
under recommended storage conditions for a specified period, typically
up to the proposed shelf life. Samples are periodically tested at defined
intervals to measure their stability and identify any changes in quality
attributes.
 Accelerated stability testing: This method involves subjecting the
product to exaggerated storage conditions, such as high temperature and
humidity, to accelerate the degradation process. The data obtained from
this testing can be used to predict the product's stability over time.
Accelerated stability testing is typically used to support a shorter shelf
life claim or to assess the impact of extreme conditions on the product.

11. • The concept of accelerated stability testing is based upon the
Arrhenius equation
Where,
K = degradation rate/s,
A = frequency factor/s,
Delta*E = activation energy (kJ/mol),
R = universal gas constant (0.00831 kJ/mol),
T=absolute temperature (K)

12.  Retained Sample stability testing :usual practice for every marketed product
for which stability data are required. Only one batch a year are selected.If the
number of batches marketed exceeds 50, stability samples from two batches
are recommended to be taken.Stability testing by evaluation of market
samples is a modified method which involves taking samples already in the
market place and evaluating stability attributes.
 Cyclic temperature stress testing :Is not a routine testing method for
marketed products.In this method, cyclic temp. stress tests are designed on
knowledge of the product so as to mimic likely conditions in market place
storage.The period of cycle mostly considered is 24 hours.The min. and max.
temp. for the cyclic stress testing is recommended to be selected on a product
by-product basis and considering factors like recommended storage temp. for
the product and specific chemical and physical degradation properties of the
products.the test should normally have 20 cycles.

13. REGULATORY REQUIREMENTS
requirements are set by regulatory authorities such as the U.S. Food and
Drug Administration (FDA) and the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use (ICH).
Some of the key regulatory requirements for drug stability testing include:
1. Good Manufacturing Practices (GMP): GMP regulations require
pharmaceutical companies to establish and follow stability testing protocols
as part of their quality control systems. GMP guidelines, such as those
issued by the FDA, outline the specific requirements for stability testing,
including testing frequency, storage conditions,expiration date and data
analysis.

14. 2. FDA Guidance for Industry: Stability Testing of Drug Substances and
Drug Products: This guidance document provides recommendations on
stability testing protocols for drug substances and drug products. It outlines
the minimum requirements for stability testing, including the number of
batches, storage conditions, and testing intervals.
3. ICH Guidelines: The ICH has developed several guidelines related to
stability testing, including :
• Q1A(R2) - Stability Testing of New Drug Substances and Products,
• Q1B - Photostability Testing of New Drug Substances and Products,
• Q1E - Evaluation of Stability Data.
These guidelines provide detailed recommendations on stability testing
protocols, including testing conditions, sample sizes, and data evaluation.

15. DRUG KINETICS
Rate And Order Of Reaction
• The velocity with which a reaction or process occurs is called its rate.
• The Conc. of drug which influences the rate of reaction or process is
called its order of reaction.
zero order reactions
first order reactions
second order reactions

16. 1) zero order reactions - the rate of reaction is independent of the drug
concentration. This means that increasing the drug concentration will not
increase the rate of reaction.
2) first order reactions - the rate of reaction is directly proportional to the
drug concentration. This means that increasing the drug concentration
will increase the rate of reaction.
3) second order reactions - the rate of reaction is proportional to the
square of the drug concentration. This means that increasing the drug
concentration will have a greater impact on the rate of reaction compared
to first order reactions.

17. Kinetic Drug Decomposition
refers to the chemical and physical changes that occur in a drug product
over time, leading to a loss of potency, efficacy, or safety.
Stability testing is conducted to assess the degradation of pharmaceutical
products under various environmental conditions, such as temperature,
humidity, light exposure, and pH.
There are several types of degradation that can occur during
stability testing:
1. Hydrolysis 2. Oxidation
3. Isomerization 4. photolysis

18. • 1. Hydrolysis: This is the breakdown of a drug molecule due to the reaction with
water. It can lead to the formation of impurities or degradation products that may be
less active or more toxic than the original drug. usually drugs such as esters, amides
and lactams undergo hydrolysis.
• 2. Oxidation: Some drugs are susceptible to oxidation, which occurs when they react
with oxygen. This can result in the formation of impurities or degradation products
that can affect the drug's efficacy or safety. loss of electrons, gain of electrons. Auto
oxidation also is responsible. Eg-tetracyclines, vit A, vit D, morphine.
• 3. Photolysis: Compounds such as ascorbic acid, riboflavin, ketoprofen, folic acid
undergo degradation on exposure to light. Sometimes coupled with thermal
reactions.
• 4. Isomerisation:Compounds get converted into a lesseffective form. Eg-Adrenaline
solutions at low pH loseactivity since its levo form is more stable than dextro form.

19. CLIMATIC ZONE FOR STABILITY TESTING

20. THANKYOU