Module 9 2024

03/09/2024

Measurements in Bioassays

Storage • Freeze drying – reduce water content (<1%) • Heat sealed glass ampoules – prevent gas exchange, moisture entry, reaction with stopper • Filled with inert gas – stop oxidation • Stored in ≤ -65 o C in the dark

USP 1032 “…reference can be stored at different conditions to maintain integrity…”

The Organisation for Professionals in Regulatory Affairs

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Measurements in Bioassays

Two tier system Primary Reference and Secondary (working) Ref

ICH Q7 Secondary Reference

• A substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis.

• Reference bridging studies are required when moving from one batch of Working Reference to another.

The Organisation for Professionals in Regulatory Affairs

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