The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug

What is the purpose of stability testing in pharmaceutical products?

The purpose of stability testing is to provide evidence on how the efficiency and integrity of a drug substance or drug product (including its packaging) vary with time under the influence of a variety of physical, chemical or microbiological changes, such as temperature, PH, humidity, light, and radiations.

What is the purpose of stress testing in stability studies?

Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used.

What is the purpose of stability?

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug

What are the examples of significant change during stability studies?

Failure to meet the specification for related substances, physical appearance, moisture content, hardness, friability, solubility, pH and other similar tests are considered as a significant change in pharmaceutical substances and products.