API
API
Nature and characteristics:
Pharmacological activity: The chemical substance in a drug that directly exerts therapeutic effects.
Clear structure: The molecular structure and physical and chemical properties have been strictly identified (melting point, boiling point, solubility, spectral data, etc.).
Strong stability: Maintains chemical and physical stability during storage and transportation.
Scalable production: Equipped with scalable chemical synthesis processes, it is suitable for industrial production.
Classification:
By source:Chemical synthesis of apis (the vast majority of small molecule drugs);Biological apis (proteins, antibodies, vaccines, etc.).
According to chemical structure:Heterocyclic derivatives (such as pyridine and imidazole derivatives);Aromatic compounds;Aliphatic compounds;Peptides.
By therapeutic area:Antibiotics;Cardiovascular drugs;Anti-tumor type;Drugs for the central nervous system;Antiviral type.
Importance:
The core of drug efficacy: determining the therapeutic effect and safety of the drug
Quality determines success or failure: Purity and impurity spectrum directly affect drug safety
The core of new drug development lies in the design of API molecules and the optimization of chemical synthesis processes