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Question

Posted on: October 10 2019

Nystatin-Preparation of storage temperature

In Farmassitente (nr138-P. 5) It is stated that magistal preparations containing nystatin should be stored outside the refrigerator. According to TMF, this must be done. What do you think of this?

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Answer

As for the Nystatin, this is indeed a difficult case. From APB there came a mailing/writing that the humidity often landed out of specifications after storage in the refrigerator. The solution was then to keep it out of the fridge.

We were here for a moment because the stability on the basis of our data can only be insured in the refrigerator and that APB has not really stood still.

In The future, manufacturers will offer their product, stating the storage conditions according to the stability to be underbuilt. If the raw material says ' keep cool '; This should be kept cool. If room temperature is present: this can be at room temperature. This can vary from manufacturer to manufacturer and from lot to lot.

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