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Moreover, real-time stability studies are conducted under recommended storage conditions. These long-term studies are essential as they help to validate the findings from accelerated studies, providing a comprehensive understanding of how the API will function during its intended shelf life. The data obtained from these stability tests inform pharmaceutical manufacturers about necessary measures for handling, packaging, and labeling, ensuring that the needs of regulatory agencies, such as the FDA or EMA, are met.
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5. Environmental Benefits With growing awareness of sustainability, the use of calcium carbonate, a naturally occurring mineral, aligns with eco-friendly practices. It can partially replace more harmful additives, contributing to the overall sustainability of plastic products.
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