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Introduction Of API
Jan 24, 2018

The definition of API in ICH Q7A is defined as a mixture of any substance or substance for drug manufacture, and also an active ingredient in pharmaceuticals when used in pharmaceuticals. This substance has pharmacological activity or other direct action in the diagnosis, treatment, symptom relief, treatment or disease prevention, or it can affect the function or structure of organism.

Effective components of the drug. Only if the drug is processed into a pharmaceutical preparation, can it become a medicine for clinical application.

According to its source, the API can be divided into two categories: chemical synthetic and natural chemical.

Chemical synthetic drugs can be divided into inorganic synthetic and organic synthetic drugs. The synthesis of inorganic medicine for inorganic compounds (very few elements), such as aluminum hydroxide, used for treatment of gastric and duodenal ulcer three magnesium silicate; organic synthesis medicine is mainly composed of basic organic chemical raw materials, drug produced by a series of organic chemical reactions (such as aspirin, caffeine, chloramphenicol, etc.).

According to its source, natural chemical drugs can be divided into two categories: biochemical drugs and phytochemicals. Antibiotics are generally produced by microorganism fermentation, which belong to the category of biochemistry. In recent years, a variety of semisynthetic antibiotics are the product of biosynthesis and chemical synthesis. In the raw materials, the proportion of the varieties, output and output value of organic synthetic drugs is the largest, which is the main pillar of the chemical pharmaceutical industry. The quality of API determines the quality of the preparation, so its quality standard is very strict. All countries in the world have made strict national pharmacopoeia standards and quality control methods for their widely used raw materials.





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