Storage requirements for APIs mainly include the following aspects:
Temperature control: APIs usually need to be stored within a specific temperature range. For example, most drugs can be stored at room temperature, with a temperature range of 10-30°C. For drugs with certain special properties, such as volatile liquids or solid preparations that are susceptible to humidity, lower temperatures and/or lower relative humidity may be required to maintain their stability. In addition, some drugs need to be stored in a cold place (2-8°C), such as biological products, vaccines, and some specific antibiotics.
Humidity control: The relative humidity of the storage environment is also very important. Generally speaking, the relative humidity of the storage environment should be controlled between 35%-75%. For solid preparations, such as tablets, capsules, etc., the relative humidity should generally be controlled between 45%-60%; while for liquid preparations, such as injections, oral liquids, etc., stricter humidity control is required to avoid microbial contamination and drug degradation.
Store away from light: Many drugs are sensitive to light, so they should be stored away from direct sunlight. These drugs should be packaged in opaque containers, such as brown containers or colorless, transparent, or translucent containers wrapped in black paper.
Sealed storage: Sealed storage can prevent dust and foreign matter from entering the container, protecting the drugs from dust or foreign matter in the environment.
Special warehouse: APIs should be stored in a special warehouse, and the warehouse should maintain a constant temperature and humidity to prevent the drugs from getting damp, mildewed, or decomposed. The warehouse should also have good ventilation facilities.
Regular inspection: A regular inspection plan for the storage and maintenance of APIs should be formulated, with clear inspection frequency and items, to ensure the accuracy of inventory information, and to deal with unqualified APIs in a timely manner.
Safety protection and emergency response: A safety protection and emergency response plan should be formulated to ensure rapid response in emergency situations.
