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Table of ContentsLONG TERM STABILITY OF CAPPED DREDGED MATERIAL DISPOSAL MOUNDS: STAMFORD NEW HAVEN NORTH AND CAP SITE 2 IN LONG ISLAND SOUND Drew A. Carey 1 , Dion Lewis, Steve Wolf, Marcia Greenblatt

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What is long term stability of?

Long term stability refers to the ability of a product, usually a pharmaceutical or cosmetic, to maintain its quality, efficacy, and safety over an extended period under specified storage conditions.

Who is required to file long term stability of?

Manufacturers and developers of pharmaceutical, biotech, or cosmetic products are required to file long term stability data with regulatory authorities to ensure compliance with quality standards.

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To fill out long term stability documentation, include comprehensive information on storage conditions, testing methods, results over time, and any deviations from expected outcomes, ensuring adherence to regulatory guidelines.

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The purpose of long term stability studies is to demonstrate that a product retains its intended quality and safety throughout its shelf life, supporting market authorization and consumer safety.

What information must be reported on long term stability of?

Information reported on long term stability should include product formulation, packaging, storage conditions, testing time points, assay results, and any observed changes in product characteristics.

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