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 ensure the chemicals and the medicine are as effective as expected.
After our pharmaceutical products or chemicals pass quality control, we pack, store, or ship them. Storage conditions also matter during the shipping process.
Generally, storage conditions include temperature, humidity, and container type.
But what temperatures, humidity levels, and container types should we use to store those chemicals? Is there guidance for us? The answer is yes. The Pharmacopeia has the best reference.
Let’s break it down into details.
1.Temperature
Due to geographical and climate differences, storage temperature requirements vary by region.
Check the following table for a general idea.
2.Humidity
Below is the European Medicines Agency GUIDELINE on DECLARATION OF STORAGE CONDITIONS from 2007.
The storage conditions must be stated on the Package Leaflet (PL). The labeling of medicinal products should also refer to the testing conditions for stability studies:
3. Container
For the container, you don’t need to worry too much.
According to the policy, the manufacturers have selected the most suitable package to protect the APIs and medicines.
You must store the container only under the conditions specified on the package label.
How do I know the storage conditions for my APIs?
Yes, you can check your country’s Pharmacopeia Standards.
Find the corresponding storage conditions in your Pharmacopeia, such as USP, EP, BP—IP, CP, etc.
Check the relevant listings to see the exact storage conditions required.
Below is a screenshot of the storage conditions for Topiramate API in USP40. The storage requirements are in the Additional Requirements section.
Disclaimer:
This content is for informational purposes only and is intended for business-to-business communication within the pharmaceutical industry. It is not intended as medical advice. The manufacture, import, and use of API must comply with all applicable laws and regulations in the relevant country or region.
This blog post is informational only and does not constitute medical advice.
Always consult a healthcare professional before starting any new medication or treatment.
Cara beli Natrium Hidroksikobalin ini di toko mana ya?
Hai, tidak tersedia garam natrium untuk Hydroxocobalamin, melainkan dalam bentuk garam HCl atau asetat. Sebagai informasi.
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