In recent months, the awareness for the impurities ethylene glycol and diethylene glycol in pharmaceutical products was increased due to several warning letters issued by the FDA and a call for action by the WHO.
Ethylen glycol (EG) and diethylene glycol (DEG) are potentially harmful impurities that can be found in pharmaceutical products. The compounds are commonly used in industrial applications, such as in the production of plastics and solvents. However, their presence in pharmaceuticals is a cause for concern due to its toxic properties.
The presence of EG and DEG in pharmaceutical products can result from various sources, including improper sourcing of raw materials or cross-contamination in manufacturing equipment. Regulatory agencies around the world have set strict limits on the permissible levels of those impurities in pharmaceutical products to ensure patient safety.
Manufacturers are required to implement robust quality control practices, including thorough testing of raw materials and finished products, to detect and prevent contamination. Regular monitoring and adherence to regulatory guidelines are crucial to ensure that pharmaceutical products are free from harmful levels of these impurities, safeguarding the health of patients, who rely on these medications.