The storage conditions for APIs and medicines

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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 the chemicals or medicines to be effective.

After our pharmaceutical products or chemicals pass the quality control, we will pack, store or ship it out. Even during the shipping process storage conditions also matter. Generally, the storage conditions include temperature, humidity, 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 temperatures are not exactly the same for different countries. Check the following table and you can get an 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 chemicals? Do I have guidance to look it up?

Yes, you can check the Pharmacopoeia Standards of your country. Find the corresponding storage conditions in your Pharmacopoeia, such as USP, EP, BP. IP, CP, etc. Check the relevant list and you will see the exact storage conditions required for the storage.
Below is a screenshot for the storage conditions for Topiramate in USP40, you can find the storage requirements from the Additional Requirements section.

Storage Condtions for Topiramate in USP40