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In the case of finished pharmaceutical products, stability testing encompasses not just the API but also the entire formulation, including excipients, which are the inactive substances used to formulate the drug. The interactions between the API and excipients can affect the overall stability of the product. For example, moisture-sensitive APIs may require specific excipients that can provide a protective barrier against moisture uptake.

6. Regulatory Status Information regarding approval by health authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), is included to indicate the API's legitimacy and market availability.

The pharmaceutical industry is a complex and highly regulated field in which active pharmaceutical ingredients (APIs) play a crucial role. An API is the substance in a pharmaceutical drug that is biologically active and is responsible for the therapeutic effect. Understanding drug APIs is vital for anyone interested in pharmacology, drug development, or the healthcare sector, as these components serve as the cornerstone of medication efficacy and safety.

4. Quality Control and Assurance

Understanding API in Pharmacy A Comprehensive Overview

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