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What is the zolbetuximab temperature excursion range?

Published

Zolbetuximab temperature excursion/extended stability for unopened 100 and 300 mg vials: 3 days at 40°C, 6 days at 30°C, 14 days at 25°C and 7 days at -20°C

During shipping/storage, three temperature excursions are allowed.1

The stability of single-dose zolbetuximab vials was also evaluated under thermal cycling, stress, and accelerated conditions.1 No impact on quality was observed from all three tests for both 100 and 300 mg vials.

  • In thermal cycling, vials were stored at 40°C for 2 hours then at -20°C for 2 hours repeated three times.
  • Under stress, vials were stored at -20°C for 1 month and at 40°C for 3 months.
  • For the accelerated condition, vials were stored at 25°C for 6 months. 

  1. Data on File.

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