FDA recommends that the manufacturer of any U.S. marketed drug product follow ICH Q3D recommendations to establish appropriate procedures for identifying and controlling elemental impurities in the drug product based on risk assessment and product-specific considerations.
Elemental impurity sources in pharmaceuticals can be categorized in these general ways:
Three classes of elemental impurities have been established based on their toxicity and likelihood of presence in the drug product:
Other elements that do not have established PDEs but may need to be considered include: Al, B, Ca, Fe, K, Mg, Mn, Na, W, and Zn
How Can Primera Help You with Elemental Impurities and Assays
With advanced Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) systems (Agilent 7900 and 7700s), Primera offers elemental impurity analysis per USP <232>, <233>, and ICH Q3D. Primera offers:
Primera also employs multiple CEM Mars microwave digestion systems to assist with our elemental impurity studies. These systems allow us to work with many drug products and other materials such as APIs, excipients and raw materials under controlled digestion conditions, and will provide greater accuracy and repeatability.
Some drug substances, drug products, and excipients require the assay of elements such as Calcium, Aluminum, and Phosphorus. Counter ions such as Sodium and Potassium can also be assayed.
We also offer quick screening of 68 elements for your early development work.
Primera Will Design Methods to Meet Your Specific Needs