Production Characteristics of API Pharmaceutical

Ⅰ. Understand API pharmaceutical

API pharmaceutical refers to API pharmaceuticals used in the production of various preparations and is the active ingredient in the preparations. Various substances prepared by chemical synthesis, plant extraction or biotechnology are used as medicinal powders, crystals, extracts, etc., but cannot be directly taken by patients. Only when API pharmaceutical is processed into pharmaceutical preparations can it become a medicine for clinical application.

Ⅱ. The production characteristics of API pharmaceutical

1. The production of API pharmaceutical is complex: the production process of API pharmaceutical has complex biological, physical and chemical reaction processes. Therefore, the production of active pharmaceutical ingredients often requires multiple unit operations, including subsequent distillation, extraction, purification, etc., and the techniques, equipment and facilities used are very complex. For example, chemical drugs are generally made from chemical raw materials with relatively simple molecular structures through a series of synthesis and processing processes, or from natural products known to have a certain basic structure through chemical structure transformation and physical processing. If you are looking for active pharmaceutical ingredient companies, Pharmasources would be a great platform for you!

2. The production risk of API pharmaceutical is high: the production of API pharmaceutical requires a large amount of raw and auxiliary materials, organic solvents (flammable, explosive, toxic), and the reaction process is accompanied by high temperature or high pressure control. Due to the flammable and explosive nature of organic solvents, there are often certain risks in their operation; in addition, the solvents used in reaction media, separations and formulations often cause chemical pollution, toxic and volatile solvent replacement research has always been a green chemistry important content of technical research.

3. API pharmaceutical production is seriously polluted. The production and synthesis of API pharmaceutical requires various side reactions, which will produce certain waste water and exhaust emissions. The resulting pollutants not only affect the quality of soil, water and ecological environment, but also cause harm to the air and operators.

During the production process, API pharmaceutical workshops usually introduce multiple drugs. These API pharmaceuticals have different properties, so many contaminants of different properties are generated after production. Faced with the reaction of multiple API pharmaceuticals, cross-contamination of materials needs to be controlled during the manufacturing process. This is also one of the goals of applying green chemistry technology.

4. The production of API pharmaceutical has high requirements on the operating environment. In the production process, measures and areas need to be taken to prevent contamination and cross-contamination, especially the production of sterile API pharmaceutical; at the same time, the production of API pharmaceutical must comply with the requirements of GMP and various laws and regulations in order to better enter the market; For the production of API pharmaceutical, GMP is the key link that affects the quality of the finished product, mainly referring to refining, drying, packaging and other links.