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High-quality pharmaceutical intermediates must comply with strict regulatory standards. These standards are set by organizations such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) to ensure the safety and efficacy of medications. The production process involves precise control of various parameters, including temperature, pH, and purity levels. For instance, ethylene glycol diacetate and sodium cumenesulfonate are common intermediates that must be produced under controlled conditions to maintain their quality and effectiveness.

Just like with APIs, stability testing for FPPs typically involves long-term, accelerated, and intermediate studies. The results help determine the product's expiration date and the specific conditions under which it should be stored. It also informs the labeling of the product, ensuring that patients and healthcare providers use the medication safely and effectively.


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- System Cleaning Periodic cleaning of cooling towers and associated components should be implemented to remove scale, biofilms, and other contaminants, thereby enhancing system efficiency.


2. Pregnancy and Lactation:

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