Progesterone

Summary:

API as well defined in ICH Q7A: Any substance or mixture of substances intended for use in the manufacture of a pharmaceutical product and which, when used in a pharmaceutical product, becomes an active ingredient of the drug. This substance has a pharmacological activity or other direct effect in the diagnosis, treatment, symptom relief, management or prevention of disease, or can affect the function or structure of the organism.

Keywords:

diagnosis symptom

CAS:

57-83-0

Name:

Specification:

USP, EP, BP, JP, CP, IP

Details

API as well defined in ICH Q7A: Any substance or mixture of substances intended for use in the manufacture of a pharmaceutical product and which, when used in a pharmaceutical product, becomes an active ingredient of the drug. This substance has a pharmacological activity or other direct effect in the diagnosis, treatment, symptom relief, management or prevention of disease, or can affect the function or structure of the organism.

The active ingredient in a pharmaceutical preparation. Raw materials are only processed into pharmaceutical preparations before they become available for clinical use.

APIs are divided into two categories according to their origin: chemically synthesised drugs and natural chemical drugs.

Chemical synthetics can be divided into inorganic and organic synthetics. Inorganic synthetic drugs are inorganic compounds (individually elemental), such as aluminium hydroxide and magnesium trisilicate used to treat stomach 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: biochemical drugs and phytochemical drugs, according to their origin. Antibiotics are generally produced by microbial fermentation and belong to the biochemical category. In recent years, a variety of semi-synthetic antibiotics have emerged, which are a combination of biosynthesis and chemical synthesis. Among the raw materials, organic synthesis of the varieties of drugs, production and output value of a large proportion, is the main pillar of the chemical pharmaceutical industry. The quality of the API determines the quality of the preparation, so its quality standards are very strict, the world for its widely used API have developed a strict national pharmacopoeia standards and quality control methods.

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