AMPAC Analytical is your premier site for the development of methods for the determination of elemental impurities. USP chapter <232> and USP chapter <233>, along with ICH Q3D, aim to standardize the allowable limits of elemental impurities. With the implementation of these limits slated for early 2018, it will be critical to get your existing APIs, Drug Products, and excipients as well as future products compliant with these procedures.
AMPAC Analytical can leverage years of sample digestion and preparation experience to develop and validate a robust elemental impurity methods. For limits less than 5 ppm, AMPAC Analytical recommends ICP-MS for the determination of elemental impurities. In addition, AMPAC Analytical is well suited to routinely test and release your products against USP<232>/ICH Q3D needs.