Photostability testing added per ICH Q1B
Ergopharm has added photostability testing to its stability programme in line with ICH Q1B, establishing by test rather than assumption whether each product needs light protection.
Amber glass and carton overwrap are frequently applied out of habit. Q1B replaces habit with a decision: the substance and the product are exposed to a defined light challenge, and the results determine whether protection is required, and if so whether the immediate container is sufficient or the outer carton must provide it.
“Amber glass should be a conclusion from a test, not a habit inherited from the last product.”
Testing runs in stages — the exposed product, then the product in its immediate container, then in its marketed pack — so that the protection claimed on the label matches the level at which protection was actually demonstrated. Both visible and ultraviolet exposure are applied to the levels the guideline specifies, with a dark control run alongside to distinguish light-induced change from thermal change.
The outcome feeds directly into the storage statement on the pack and into the handling instructions given to distributors.
Key facts
- Guideline
- ICH Q1B photostability testing
- Staged
- Exposed product → immediate container → marketed pack
- Exposure
- Visible and ultraviolet, with a dark control
- Feeds
- Label storage statement and distributor handling advice
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.