stability testing as per ich guideline for quality control of pharmaceuticals

1. Stability testing of
pharmaceutical dosage form
as per ICH guideline

2. Content

3. Introduction

4. Stability Testing Protocols

5. 2.Container and Closure

6. 3. Orientation of storage of containers
Samples of the solutions, dispersed
systems and semi-solid drug
products for stability studies must
be kept upright and positioned
either inverted or on the side to
allow for full interaction of the
product with the container-closure.
This orientation helps to determine
whether the contact between the
drug product or solvent and the
closure results in the extraction of
chemical substances from the
closure components or adsorption
of product components into the
container-closure

7. 4.Sampling Time Point

8. Stability time point table

9. 5.Sampling Plan

10. Continue………

11. Test Storage Condition

12. Test storage condition table

13. Test Parameters

14. Testing Method
Reference; -
1) Bajaj Sanjay, Singla Dinesh and Sakhuja Neha ,
Reference; -
1) Bajaj Sanjay, Singla Dinesh and Sakhuja Neha ,Stability
testing of Pharmaceutical Products ,Journal of Applied
Pharmaceutical science