ICP Multi Element ICH Q3D Oral Standards

ICP Multi Element ICH Q3D Oral Standards are built around the elemental impurity classes that apply to oral pharmaceutical products. Pharmaceutical quality control laboratories and contract testing laboratories use them when calibrating ICP-OES or ICP-MS for tablets, capsules and oral liquids.

Six Reagecon standards are listed. They include 3 element Class 2A and Class 2B standards in 2% nitric acid, a 3 element Class 3 standard in 5% nitric acid with trace tartaric acid and hydrofluoric acid, and a 4 element Class 3 standard in 10% nitric acid.

Work from the elemental impurity risk assessment for your product to decide which classes you need to calibrate for, then match the acid matrix to your digestion procedure. Separate inhalation and parenteral sets cover the other routes of administration. Lancetech Limited can quote these oral route standards on request.