Generic filters
Exact matches only
Generic filters
Exact matches only
Header Artwork
Header Artwork

Author: Dennis Jenke





June 6, 2019

The Use and Utility of General Chemistry Data in Extractables Assessment

This White Paper describes how General Chemistry Data obtained in controlled extraction studies, such as pH, UV absorbance and total organic carbon (TOC), is reported, used and discussed as part of a rigorous extractables assessment.

See Blog

May 1, 2019

Use of Exaggerated Surface Area to Solution Volume Ratios in Extractables Studies; Equilibrium Case

The goal of this whitepaper is to provide guidance and justify appropriate practices about the proper use of exaggerated test article surface area to extraction solution volume ratios in exaggerated extractables studies.

See Blog

March 25, 2019

Establishing the Proper Alcohol/Water Proportion for Simulating Solvents Used in Controlled Extraction Studies

The purpose of this paper is to provide guidance on determining the proper alcohol/water proportion for simulating solvents used in controlled extraction studies relevant to drug products that are packaged in plastic container systems, administered via plastic devices or manufactured...

See Blog

February 18, 2019

Use of Accelerated Conditions in Extractables and/or Leachables Studies

The purpose of this paper is to consider the scientific basis for accelerated contact conditions (via the proper combination of contact temperature and duration) for studies which involve the migration of substances (either extractables or leachables) from plastics and into...

See Blog
of 2
Footer Artwork