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Forced Degradation

Pharmaceutical companies need to have stability indicating methods in place to be able to detect products of drug instability.

Here are five major degradation pathways:

Acid Hydrolysis

Damage from an acid can cause loss of structural components necessary to the molecule

Base Hydrolysis

Damage from a base can cause loss of structural components necessary to the molecule

Oxidative Degradation

Change in number or types of chemical bonds

Exposure to Heat

Exposure to heat can cause a molecule to lose necessary critical functional groups

Exposure to Light

Light sensitivity can cause molecule to fall apart and become ineffective or toxic

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.