Extractables and Leachables Testing: Emerging Opportunities for Service Providers

During drug product manufacturing and fill / finish, it is important to consider not only the impurity profiles of the drugs, but also identify potential sources of contamination in the containers / packaging material used. due to high variability in the type of impurities (organic (volatile, non-volatile or semi- volatile compounds) or inorganic (metals or salts) elements) that are usually extracted / leached out of various manufacturing components and container closures, it is not possible to identify, characterize and quantify all extractables, using a single analytical technique. Presently, a number of companies offer services for extractables and leachables testing, and such offerings have grown to become an important segment of the overall pharmaceutical industry.

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