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Stability Test

The purpose of stability testing is to provide evidence that under influence of a variety of environmental factors the quality of a product varies with time.It helps to establish a re-test period or a shelf life for the product and recommended storage conditions.

Stability Testing is categorized in three different studies.

1) Long term stability testing for 12 months

2) Intermediate 6 months

3) Accelerated for 6 months

Stability testing is conducted at room temperatures to reproduce actual storage conditions.

Accelerated stability testing is carried out at higher temperatures to simulate long term.

At least three primary batches of the product should be submitted for testing.