Difference between pharmaceutical intermediates and APIs

Pharmaceutical intermediates and APIs belong to the fine chemical industry.

Pharmaceutical intermediates: chemical raw materials or chemical products used in the process of pharmaceutical synthesis, are intermediate products in the process of producing APIs and can be further processed into APIs It does not require a production license for the drug substance, and can be produced in an ordinary chemical plant. As long as it reaches a certain level, it can be used for the synthesis of the drug substance.

Active Pharmaceutical Ingredients (APIs): Pharmaceutical active ingredients, which are the basic substances that constitute the pharmacological effects of pharmaceuticals, and are prepared by chemical synthesis, plant extraction, or biotechnology. Only when the drug substance is processed into a pharmaceutical preparation can it become a drug for clinical application. The quality of the drug substance determines the quality of the preparation, so its quality standards are very strict. Countries around the world have formulated strict national pharmacopoeia standards and quality control methods for their widely used drug substances.

The drug substance is an active product that has completed the synthetic route, and the intermediate is a product in one place in the synthetic route. The API can be directly formulated, and the intermediate can only be used to synthesize the next product. Only through the intermediate can the API be manufactured.

From basic chemical raw materials to chemical preparations, complex chemical and physical processes are required. The production of chemical raw materials and intermediates concentrates the main synthetic procedures and technical links, which is the prerequisite and important guarantee for the development of the chemical pharmaceutical industry. The complete chemical and pharmaceutical industry chain consists of basic chemical raw materials, pharmaceutical intermediates, chemical raw materials and chemical preparations.