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Analytical Methods

How can we compare data from different labs when the column is not exactly the same or determinant parameters not harmonized? We have included additional standards to demonstrate similar chromatographic range using different columns and instruments.  The widest...

Scope and Application

What is the expectation with regard to quality sign off of Extractables and Leachables data? The Bioprocessing industry is governed by cGMP. As such any data that are used to make quality decisions must meet minimum data integrity and traceability standards. It is the...

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