What is the difference between an API and a finished drug?
Now, many API companies have started or are preparing to transform and upgrade to make preparations. However, the difference between the two is not as far as outsiders see it, they are just medicines.
For APIs, many of the raw and auxiliary materials are large chemical species, such as sodium hydroxide and hydrochloric acid. Therefore, the sampling requirements of raw material pharmaceutical factories and preparation factories are different. It doesn't matter too much. Even if the sampling brings in foreign matter and microorganisms, there are many steps in the whole production process, such as centrifugation, filtration, and refinement, which can remove foreign matter and microorganisms. Packaging needs to be done in a clean area to ensure that foreign objects and microorganisms are not introduced.
As for the excipients, there is basically no chemical process in the production process of the preparation. For oral chemical preparations, the main thing is to mix the API and excipients and press them into tablets. It is brought to the finished product, so the sampling requirements for raw and auxiliary materials of preparations are very strict, and the sampling requirements for finished APIs are of the same level, and they should be sampled in a clean environment.
Degradation research of API, including: high temperature, high humidity, oxidation, light, different pH value on Q1A;
Preparations: including light experiments as well as specific experiments for specific varieties
Requirements for process control:
The preparation has stricter process control requirements. For example, the wrong excipient is used. If it is an excipient that does not affect the dissolution and hardness indicators, then we can't actually detect it. Because the content test, the excipients are filtered out.