Standards for Elemental Impurities in Pharmaceuticals ICH Q3D
Reagecon has responded to the changes in the test methods of all the major pharmacopoeias by developing an outstanding and complete range of ultrapure elemental impurity standards. The products are formulated specifically for ICP-OES, ICP-MS or any Atomic Absorption technique. These standards are offered in exactly the concentrations mandated in the pharmacopoeias as being the permitted daily exposure limits (PDE’s), depending on ingestion route Oral, Parenteral or Inhalation.
Our products can be used for instrument calibration, instrument qualification, quality control or method validation. All of the products are manufactured in an ISO 7 clean room environment, using pure materials (where possible) of either 99.995 or 99.999% purity. The products are certified gravimetrically and verified using a state of the art ICP-MS.