GDUFA Research Outcomes

Nitrosamines

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to impurities such as nitrosamine drug substance related impurities (NDSRIs) that may arise in drug products, including generic products.

• All(33)
• Posters(0)
• Presentations(22)
• Papers(11)

• Determination of Nitrite in Pharmaceutical Excipients: Air as Source for Higher Nitrite Levels

  Grahek, R

• Control Strategies for NDSRIs Originating from Impurity Amines in APIs

  Ehlert, M

• Use of a Novel Technology, the In Vitro Dissolution Absorption System, to Investigate the Effects of Antioxidants on the Intestinal Permeation of BCS Class III Drugs

  Bode, Chris