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Articles by Impact Analytical

Impact Analytical


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The Importance of Possessing Good Polymer Chemistry Knowledge in Conducting Extractables/Leachables Studies
April 11, 2014

Extractables and Leachables studies are an important part of the development cycle of any new drug product. It is important that an appropriate packaging system is chosen such that the product is stable and protected from degradation. It is equally important that this packaging system does not affect the purity of the product by leaching chemicals into the product. Rigorous extractables and leachables testing can ensure the proper packaging system is chosen, and an integral part of this testing regiment includes an extensive knowledge polymer chemistry.

Analysis for Polysorbate 80 Using New High Performance Liquid Chromatography (HPLC) Method with Charged Aerosol Detection (CAD)
June 26, 2013

Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) is a common nonionic surfactant, emulsifier and solubilizer that is used in a wide variety of industries and applications. Polysorbate 80 is typically used in food products, cosmetics, medications, vitamins, and vaccines. There can be many reasons a company may need to determine the exact amount of polysorbates in their material. For example, companies may need to determine AIG limits in their products, validate analytical methods for product production, or require the information for reverse engineering purposes. Thus, a well-developed analytical method is crucial for accurately quantitating polysorbates.

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