ICP Multi Element ICH Q3D Parenteral Standards

ICP Multi Element ICH Q3D Parenteral Standards address the elemental impurity classes relevant to injectable and infused pharmaceutical products. Sterile product manufacturers and the laboratories that test for them use these standards to calibrate ICP-OES and ICP-MS methods.

Five Reagecon standards are listed: a 4 element Class 1 standard in 5% nitric acid, 3 element Class 2A and Class 2B standards in 2% nitric acid, and a 7 element Class 2B standard in 10% hydrochloric acid, giving a choice of matrix for the Class 2B elements.

Choose by class according to your risk assessment, and pick the Class 2B matrix that matches the acid used in your sample preparation so that standards and digests behave alike. The oral and inhalation sets, together with a general ICH Q3D standard, are in the adjacent sections. Lancetech Limited can quote parenteral standards on request.