The stability test protocol should define the test parameters that would be used for evaluation of the stability samples. The tests that monitor the quality, purity, potency, and identity which could be expected to change upon storage are chosen as stability tests.

Why stability studies are required?

Stability testing studies; how long a pharmaceutical product can be stored at normal and accelerated conditions without any degradation. This study helps to determine the shelf-life of that product. Storage Condition Recommendation: Different products require different storage conditions.

What is in use stability?

INTRODUCTION. The purpose of in-use stability testing is to establish a time period during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured).

What does stability study mean?

Stability studies are performed in life sciences, chemical, and food and beverage industries to determine the effects of environmental conditions on product quality. Stability studies provide the supporting data that companies use to establish product storage requirements and expiration dating.

What are the 3 types of stability explain?

There are three types of equilibrium: stable, unstable, and neutral.

What is the condition for stability?

The stability condition of a system in its final state is where all the links are | xij | ≈ 1 and xij dxij/dt > 0; either xij increases to 1 or it decreases to − 1. Fig. 5 represents a jammed state, where positive links are within a triad, and negative links are between different triads.