The storage conditions for APIs and medicines

It is essential to know how to store your APIs and medicines.

You need to confirm the storage conditions even before you get them.

Proper storage conditions will make sure the chemicals and the medicine are as effective as expected.

After our pharmaceutical products or chemicals pass quality control, we will pack, store, or ship them out. Even during the shipping process storage conditions also matter.

Generally, the storage conditions include temperature, humidity, and type of container.

But by what temperature, humidity, and container types should we store those chemicals? Is there guidance for us? The answer is yes. Pharmacopoeia has the best reference.

Let’s break it into details.

1.Temperature

Due to geographical and climate differences, the storage temperature requirements are not the same in different regions.

Check the following table and you can get a general idea.

Storage Temperature For Apis and Medicines

2.Humidity

Below is the European Medicines Agency GUIDELINE on DECLARATION OF STORAGE CONDITIONS from 2007.

It requires the storage conditions should be stated on the Package Leaflet (PL); The labeling of medicinal products should also refer to the testing conditions for stability studies:

Storage Humidity requirements for apis and medicines

3. Container

For the container, you don’t need to worry too much about it.

According to the policy, the manufacturers have already selected the most suitable package to protect the APIs and medicines.

You only need to put the container under storage conditions according to the package label requirements.

How do I know the storage conditions for my APIs?

Yes, you can check the Pharmacopoeia Standards of your country.

Find the corresponding storage conditions in your Pharmacopoeia, such as USP, EP, and BP. IP, CP, etc.

Check the relevant listings and you will see the exact storage conditions required for the storage.
Below is a screenshot of the storage conditions for Topiramate in USP40, you can find the storage requirements in the Additional Requirements section.

Storage Condtions for Topiramate in USP40
Screenshot of Topiramate MOA by USP40

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