Detailed analysis of APIs

I. Definition and nature

An API, known in English as Active Pharmaceutical Ingredient, or API for short, is any substance or mixture of substances used in the manufacture of pharmaceuticals. These substances, when used in pharmaceuticals, become an active ingredient of the drug and have pharmacological activity or other direct effects on the diagnosis, treatment, symptomatic relief, or prevention of disease, and are capable of affecting the function or structure of the organism. APIs are not medicines that can be taken directly by patients, but exist in the form of powders, crystals, extracts, etc., and need to be transformed into medicines that can be used by patients through a specific formulation process.

Second, the source and preparation

The sources of APIs are wide-ranging, mainly including chemical synthesis, plant extraction and biotechnology preparation and other ways. Chemical synthesis method is to get the API through chemical reaction, this method has the advantages of high yield, high purity, cost control, etc.; plant extraction method is to extract the active ingredients from natural plants as API, the API obtained by this method usually has natural active ingredients, with relatively small side effects; biotechnology preparation method utilizes the microbial fermentation, recombination and other modern biotechnological means to produce API, which is widely used in the field of biologics. This method is widely used in the field of biological products.

Classification and use

APIs can be classified according to different classification standards, such as chemical APIs, plant-based APIs and biological APIs, etc.; according to the product cycle can be divided into patented APIs and generic APIs. Different types of APIs have a wide range of applications in the pharmaceutical field, they are used to manufacture a variety of pharmaceutical preparations, such as tablets, capsules, injections, eye drops, etc., to meet the therapeutic needs of different diseases.

Fourth, quality control and safety

As APIs act directly on the human body, there are extremely high requirements for their quality. The quality control standards for APIs are usually more stringent than those for preparations, and it is necessary to ensure that their purity, stability, impurity content and other indicators in line with relevant regulations and standards. At the same time, long-term exposure to low doses of certain APIs may pose a potential risk to human health, such as heavy metals APIs may lead to damage to the nervous system, digestive system and other multi-systems, organic solvents APIs may cause skin irritation, respiratory distress and other symptoms. Therefore, in the production, storage and use of APIs, it is necessary to strictly comply with the relevant safety regulations to ensure the safety of personnel and the environment.