Today's topic is stability studies of pharmaceutical products. ICH Topic Q 1 A (R2) for stability of drug substances and products is a great chapter that covers general topics that cannot go into much detail about it. Below you can find a free preview of a presentation that takes a closer look in stability studies and is recommended to all consultants and life-sciences professionals.

1. QualityControl
Stability Programof an Active
Pharmaceutical Ingredient (API)
Dimitris Papamatthaiakis
Pharma Life-cycle Consultancy

2. Outline
 Scope of presentation
 Stress Testing
 Selection of Batches
 Container Closure System
 Specifications: Stability indicating quality parameters
 Testing Frequency
 Storage Conditions
 Evaluation of data
 Bracketing/Matrixing
 Common deficiencies
 Further reading

3. StabilityProgramof an
API
Scope of presentation

4. Stability
Programof an
API
Scopeofpresentation
 Critical in drug development
 Understanding of the molecule
 Essential for developing analytical methods
 Essential for selecting packaging for drug substance
and drug product
 Essential for choosing storage conditions for drug
substance and drug product

5. StabilityProgramof an
API
Stress testing

6. Stability
Programof an
API
Stresstesting
 Identification of degradation pathways
 Identification of degradants
 Determination of which type(s) of stress affect the
molecule
– Photostability
– High Temperature
– Low Temperature
– Oxidation
– pH extremes
– Water

7. Stability
Programof an
API
Stresstesting
 Requirement: 1 API batch.
 Photostability testing: generally as per Q1B
 If “Protect from light” is stated in one of the officially
recognized pharmacopoeia for the API, it is sufficient to
state “protect from light” on labeling, in lieu of
photostability studies, when the container closure
system is shown to be light protective.

8. Stability
Programof an
API
Stresstesting
 Typical Stress conditions
Stress factor Condition
Heat +80°C ± 2°C
Humidity 75 % RH ± 5 % or
greater
Acid Hydrochloric acid
(0.1 M)
Base Sodium hydroxide
(0.1 M)
Oxidative 3 % Hydrogen
peroxide
Photolytic UV-light stress

9. Stability
Programof an
API
Stresstesting
 Typical Stress conditions – Heat
 Container: usually glass container
 Check points:
 day of preparation (T0)
 at 24h,
 at 48h
 at 72h
 Measurement: before and after treatment/storage

10. Stability
Programof an
API
Stresstesting
 Typical Stress conditions – Humidity
 Container: in an open glass container with the opening
protected using aluminium foil
 Check points:
 day of preparation (T0)
 at 24h,
 at 48h
 at 72h
 Measurement: before and after treatment/storage

11. Stability
Programof an
API
Stresstesting
 Typical Stress conditions – Acid/Base
 Container: test vial or preparation vssel
 Check points:
 day of preparation (T0)
 at 24h,
 at 48h
 at 72h
 Measurement: before and after treatment/storage
 Is there significant degradation?
 Determine degradants

12. Stability
Programof an
API
Stresstesting
 Typical Stress conditions – Oxidation
 Container: test vial or preparation vessel
 Goal is significant degradation (typically 10-30% of
API)
 Check points:
 day of preparation (T0)
 at 24h,
 at 48h
 at 72h
 Measurement: before and after treatment/storage
 Determine whether protective packaging is required
 Determine if an antioxidant should be considered for
the drug product formulation

13. This is a free preview copy of the original training “Quality Control Stability Program of an Active Pharmaceutical Ingredient (API)”
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