The Crucial Role Temperature Plays in cGMP API Storage
Everyone who works closely with drugs knows the importance of properly dispensing pharmaceuticals. Mistakes can cause harm to a consumer’s well-being if manufacturers and storage facilities don’t follow strict protocols.
Continue reading to understand the crucial role temperature plays in cGMP API storage. This article will provide insight into this aspect of the pharma industry.
What Is API?
API is an acronym for “active pharmaceutical ingredients.” These are the active ingredients contained in medications, which you may think are raw materials. But there are subtle differences between raw materials and API.
API works with the inactive ingredient to deliver the intended outcome of the medicine. The inactive ingredient will help produce the effects of API.
Temperature Impacts Drug Stability
All pharmaceuticals need proper temperature control to provide the intended effects. Temperature impacts the stability of medications’ API. Improper temperature control can alter a medication’s physical properties, and the drug may degrade or develop impurities. You might notice an odor, color change, or new texture.
These impurities and physical changes indicate the medication won’t work or could harm the consumer. Once the consumer has the pharmaceutical at home, light, humidity, and heat can damage the product. Customers should read storage recommendations to ensure their medications don’t degrade prematurely.
Proper Storage Is Essential
Each drug has a specific margin of error for the correct temperature storage. These strict guidelines ensure the pharmaceutical remains within the recommended temperature range. A two-degree difference could ruin a medication’s API.
Here are a few cGMP guidelines from the World Health Organization regarding these products:
- Store in an environment with no odor or light
- Store in an environment with proper ventilation
- Follow the temperature range set by the pharmaceutical manufacturer
- Keep humidity levels at 60 percent or lower
Most pharmaceutical companies depend on reliable storage facilities to store the medications properly. Simply put, there’s no room for error.
Moravek is a company whose cGMP quality control and analytical lab services include method transfer, development, feasibility, radiochemical studies, storage, and stability. We understand there’s no room for mistakes, and we will ensure product production follows all cGMP guidelines.
Temperature plays a crucial role in cGMP API storage. Failure to follow temperature protocols can cause a drug to degrade prematurely and harm the consumer.