Introduction To Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredient (API)
The complete definition of active pharmaceutical ingredients in ICH Q7A is any substance or mixture of substances intended for use in pharmaceutical manufacturing, and when used in pharmaceuticals, becomes an active ingredient in the drug. This substance has pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment, or prevention of diseases, or can affect the function or structure of the body.
The active ingredients of the medication. Raw materials must be processed into pharmaceutical preparations in order to become clinically applicable medicines.
Raw materials are divided into two categories based on their sources: chemically synthesized drugs and natural chemical drugs.
Chemical synthetic drugs can be divided into inorganic synthetic drugs and organic synthetic drugs. Inorganic synthetic drugs are inorganic compounds (rarely elements), such as aluminum hydroxide, magnesium trisilicate, etc. used for the treatment of gastric and duodenal ulcers; Organic synthetic drugs are mainly drugs made from basic organic chemical raw materials through a series of organic chemical reactions, such as aspirin, chloramphenicol, caffeine, etc.
Natural chemical drugs can also be divided into two categories based on their sources: biochemical drugs and phytochemical drugs. Antibiotics are generally produced by microbial fermentation and belong to the category of biochemistry. The various semi synthetic antibiotics that have emerged in recent years are products that combine biosynthesis and chemical synthesis. Among raw materials, the variety, production, and output value of organic synthetic drugs account for the largest proportion and are the main pillar of the chemical pharmaceutical industry. The quality of raw materials determines the quality of formulations, therefore their quality standards are very strict. Countries around the world have formulated strict national pharmacopoeia standards and quality control methods for the widely used raw materials.