Determination of Surface Visible Residue Limits on Pharmaceutical Plant Equipment
February 2nd 2013The minimum amount of residue that can be visually detected is demonstrated for a small number of active pharmaceutical ingredients (APIs) on a range of different surface materials.
Improving Inhaled Product Testing: Methods for Obtaining Better In vitro-In vivo Relationships
February 2nd 2013Even in an industry in which all product development is complicated by the intricacies of human biology, orally inhaled products (OIP) stand out as singularly demanding.
Modernization of the Standards for Elemental Impurities
February 2nd 2013Recent activity in standards-setting organizations has raised interest in the impact of testing for impurities that may enter the product before it is mined or harvested or even due to intentional use of some reagents.