ICP Multi Element ICH Q3D Inhalation Standards

ICP Multi Element ICH Q3D Inhalation Standards group the elemental impurities relevant to inhaled pharmaceutical products according to the ICH Q3D classes. Pharmaceutical QC and contract laboratories validating elemental impurity methods for inhalation dosage forms use them to calibrate ICP-OES and ICP-MS.

Five Reagecon standards are listed, covering each class: 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 3 standard in 2% nitric acid with trace tartaric acid and hydrofluoric acid.

Select the class standards that match the elements your risk assessment requires you to control for the inhalation route, and match the matrix to your digestion. Oral and parenteral equivalents, and a general ICH Q3D standard, are listed in the neighbouring sections. Lancetech Limited can quote the inhalation set on request.