stability test

Question 1

This form of stability testing is conducted on drugs for the same duration as the recommended shelf life.

Answer 1

Real-Time Stability Testing​

Question 2

a product is stressed at
several high (warmer than ambient) temperatures and the amountof heat input required to cause product failure is determined

Answer 2

Accelerated stability testing

Question 3

In this study, the stability
samples are tested at predetermined intervals i.e. if a product has
shelf life of 5 years, it is conventional to test samples at 3, 6, 9, 12,
18, 24, 36, 48, and 60 months.

Answer 3

Retained Sample Stability Studies

Question 4

This testing procedure is not compulsory and drugs undergo this test on a case to case basis. ​

In this, the minimum and maximum temperature conditions are mimicked in a controlled environment and the drugs are exposed to these conditions for 24 hours and the changes if any are noted

Answer 4

Cyclic Temperature Stress Testing

Question 5

The following stability evaluation is conducted for tablet:

Select one or more:

Microbial limit.

pH.

Appearance.

Odour.

Colour.

Answer 5

Appearance.

Odour.

Colour.