Extractables And Leachables
The goal of extractable and leachable studies is to identify chemicals released or migrated from product or packaging components such as rubber, plastic and glass under various conditions of normal use.
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•Brochure: Cyanta Analytical Services
The goal of extractable and leachable studies is to identify chemicals released or migrated from product or packaging components such as rubber, plastic and glass under various conditions of normal use. Extractables are contaminants that are observed when materials are exposed to stessed solvent conditions such as elevated temperatures and varying polarities. Leachables are a subset of the observed extractables for a given test sample and are observed in the drug product/medical device media under conditions of intended use. Extractables are often assessed under accelerated migration studies to further assist in developing leachable methods. As a final step, method(s) appropriate to quantify leachables are validated and are used in long term stability studies
•Brochure: Cyanta Analytical Services
•Brochure: Cyanta Analytical Services
The goal of extractable and leachable studies is to identify chemicals released or migrated from product or packaging components such as rubber, plastic and glass under various conditions of normal use. Extractables are contaminants that are observed when materials are exposed to stessed solvent conditions such as elevated temperatures and varying polarities. Leachables are a subset of the observed extractables for a given test sample and are observed in the drug product/medical device media under conditions of intended use. Extractables are often assessed under accelerated migration studies to further assist in developing leachable methods. As a final step, method(s) appropriate to quantify leachables are validated and are used in long term stability studies
Extractables and leachables may be composed of both organic substances (packaging raw materials, additives, stabilizers, accelerants, degradent and reaction products) and inorganic substances (metals, oxides, acids, etc.). We leverage our experience with polymers, metals, pharmaceutical products and atypical matrices to characterize the extractable profile of your medical device. Cyanta's analytical equipment, which includes GC/MS, LC/MSn, ICP-MS and many others, provides us with the tools necessary to characterize, identify and quantify the extractables and leachables in your product.
Click Here To Download:•Brochure: Cyanta Analytical Services
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