Forced Degradation is the testing of a drug product or drug substance using situations more taxing than those if conditions were simply accelerated. This type of stability testing is designed to demonstrate various degradation pathways within the product or substance and assists with the development of the product itself, along with its packaging. Within forced degradation testing, there is a subset of studies known as photo-stability. The guidelines are outlined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the FDA. As the ICH Topic Q1B document states, “The intrinsic photostability characteristics of new drug substances and products should be evaluated to demonstrate that, as appropriate, light exposure does not result in unacceptable change.”1
They recommend a range of different studies that address potential areas of concern:
A systematic approach to photostability testing is recommended covering, as appropriate, studies such as:
(i) Tests on the drug substance;
(ii) Tests on the exposed drug product outside of the immediate pack; and, if necessary,
(iii) Tests on the drug product in the immediate pack; and, if necessary,
(iv) Tests on the drug product in the marketing pack.1
The type of lights used in photo-stability are also described. They offer options, including:
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- …any light source that is designed to produce an output similar to the D65/ID65 emission standard…
- A cool white fluorescent lamp designed to produce an output similar to that specified in ISO 10977 (1993) …
- A near UV fluorescent lamp having a spectral distribution from 320 nm to 400 nm with a maximum energy emission between 350 nm and 370 nm…1
Additionally, temperature control should be maintained to minimize changes and variations.
Finally, these guidelines also provide and elucidate the differences between procedures for drug products and drug substances. It is a crucial reference for administering or simply learning more about photo-stability forced degradation testing.
AMPAC Analytical has the equipment and expertise to provide comprehensive photo-stability studies for your products. Additionally, we have high-resolution and triple-quadrupole mass spectrometers to aid in the identification of potential degradants. Contact us today to learn how AMPAC Analytical can support your photo-stability needs.
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