Stability testing is a routine procedure performed on drug substances and products, involved at various stages of product development.
Pharmaceutical products can deteriorate with time (degradation of the active drug and/or the excipients). The purpose of stability testing is to demonstrate how packaged and unpackaged pharmaceutical products change with time in various temperature, humidity and light conditions. Data is used to help establish product shelf life and storage conditions.
The tests are performed in controlled chambers. They aim at evaluating the effects of air and humidity during storage:
Migration from packaging and closure systems of compounds such as THF, Poly Aromatic Hydrocarbons, biphenols, nylon and nitrosamines
Modification of the organoleptic properties including appearance, hardness and moisture
Change in the potency, availability and microbial quality
Presence of degradation products and impurities
These tests have to be performed following strict regulations.
The main types of testing are:
Long term, which aims at mimicking the conditions the product is likely to be exposed to through its normal life (if ambient conditions are to be used the climate of the intended region will also be taken into account)
Stress testing, where the product is exposed to conditions likely to accelerate the normal aging process.
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