api in pharma meaning

Popular tags

Popular on the whole site

The stability testing of APIs generally begins during the early stages of drug formulation. APIs are the substances in pharmaceutical products that provide therapeutic effects; therefore, their stability is crucial. The primary goal is to ascertain the degradation pathway of the API and to determine the appropriate storage conditions that will maximize its shelf life. Tests typically include accelerated stability studies, where samples are subjected to higher-than-normal temperatures and humidity levels to expedite degradation processes. These studies help predict how the API will behave under regular storage conditions.


116325.00

The API manufacturing process begins long before the actual production. It starts with drug discovery, where researchers identify potential compounds that may be effective in treating specific diseases. This phase often involves extensive screening, synthesis, and testing of chemical compounds in labs. Once a lead compound is identified, it undergoes preliminary studies to assess its safety and activity. This stage may take several years and requires collaboration between chemists, pharmacologists, and clinical researchers.


Importance of API Factories


Chemical

Regulatory Framework


api drug product

api

Popular articles

Links