The production of APIs is governed by stringent guidelines imposed by regulatory agencies such as the FDA and EMA. Manufacturers must adhere to Good Manufacturing Practices (GMP), which ensure that APIs are produced consistently and controlled to quality standards. This regulatory scrutiny is crucial as it protects public health by ensuring that only safe and effective medications reach the market.
The journey of an API begins in the laboratory, where chemists and biologists work to identify and develop compounds that can potentially treat diseases. This process often involves extensive research, testing, and optimization of the molecular structure to enhance efficacy and safety. The goal is to identify a molecule that can effectively interact with biological systems to modulate a specific pathological process.
The formulation of pharmaceutical products, including the selection of ingredients, is subject to strict regulatory oversight. Manufacturers must adhere to Good Manufacturing Practices (GMP) to ensure that every aspect of production meets safety and quality standards. This includes meticulous sourcing of ingredients, thorough testing, and proper labeling.
Dissolved gases, particularly oxygen and carbon dioxide, can also pose significant risks in boiler systems. Oxygen facilitates corrosion, while carbon dioxide can combine with water to form carbonic acid, lowering pH and increasing corrosive potential. Deaerators are utilized to remove these gases from the feedwater, but often, chemical oxygen scavengers such as hydrazine or sulfites are included in the treatment regimen. These compounds effectively neutralize dissolved oxygen, protecting the boiler from corrosion.