Sterile API

APIS means a chemical substance specially supplied for the production of pharmaceutical preparations; sterile APIs are those that do not contain any active microorganisms, such as molds, bacteria, viruses, etc.

serile API is the foundation and source of pharmaceutical preparation enterprises, and the quality assurance level of its production is directly related to drug safety;The chemical compatibility of the filter element is strictly required in the process of material-liquid filtration and most of the solvent, especially the corrosive solvent filtration. Kinda Filtration combined with its laboratory process validation services, to provide pharmaceutical enterprises with constant production process in line with predetermined standards and quality characteristics of filtration products

According to its source, APIS are divided into chemical synthetic 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, such as aluminum hydroxide and magnesium trisilicate for the treatment of gastric and duodenal ulcer, etc.

Organic synthetic drugs are mainly made of basic organic chemical raw materials, through a series of organic chemical reactions and drugs (such as aspirin, chloramphenicol, caffeine, etc.).

Natural chemical drugs can also be divided into biochemical drugs and phytochemical drugs according to their sources. Antibiotics are generally produced by microbial fermentation and belong to the category of biochemistry. In recent years, a variety of semi-synthetic antibiotics are the combination of biosynthesis and chemical synthesis products. Among apis, organic synthetic drugs account for the largest proportion of variety, yield and output value, which is the main pillar of chemical pharmaceutical industry. The quality of the API determines the quality of the preparation, so its quality standards are very strict. All countries in the world have formulated strict national pharmacopoeia standards and quality control methods for the widely used APIS.