AMPAC Analytical is your premier site for the development of methods for the determination of elemental impurities. Now in effect, USP Chapters <232> and <233>, along with ICH Q3D standardize the allowable limits of elemental impurities. With these limits required as of early 2018, it is critical to get your APIs, Drug Products, and excipients compliant with these procedures.
AMPAC Analytical leverages years of sample digestion and preparation experience to develop and validate 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 in compliance with USP <232>, <233>, and ICH Q3D regulations for elemental impurity control.