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The International Conference on Harmonisation (ICH) has issued Guidelines for Elemental Impurities to limit patient exposure to potentially toxic elements above a specified limit during their course of treatment.
Elemental impurities can be introduced, either intentionally or unintentionally, by excipients, manufacturing equipment, packaging (primary and secondary) and, of course, the drug substance itself. The ICH Q3D guideline identifies three key components to risk assess elemental impurities:
What are the elements included in the Guideline?
The elements evaluated are organized into several classes (listed below):
|Class||Elements||Should Elements be included in Risk Assessments?|
|Class 1||As, Cd, Hg, and Pb||Yes|
|Class 2A||V, Mo, Se, and Co||Yes|
|Class 2B||Au, Tl, Pd, Pt, Ir, Os, Rh, Ag and Ru||Yes, only if intentionally added|
|Class 3||Sb, Ba, Li, Cr, Cu, Sn, and Ni||Depends on route of administration|
|Other||Al, B, Fe, Zn, K, Ca, Na, Mn, Mg, and W||No|
How can I understand what impurities my container closure components are contributing to my Drug Product?
First, let’s understand a key difference between extractables, potential elemental leachables and elemental impurities.
Extractables, in this case, are elements which can leach from a component. These are determined based on components being extracted under exaggerated conditions (i.e. acid solutions) at high temperatures. Components are screened for elemental extractables using generally well characterized methods. Result for extractable screening studies are reported as semi-quantitative until a method would be optimized and validated for specific elements. The purpose of extractable studies is to understand semi-quantitatively which elements can be extracted from the container closure system and use that knowledge to make decisions regarding relative risk. If there are elements of known concern at a given level and/or oxidation state, a method may need to be optimized because the screening method may or may not be suitable.
Potential Elemental Leachables are elements found in a solvent similar to the drug product and therefore can indicate the likelihood of occurrence in the final drug product.
Elemental Impurities are extractable elements that have been found in the final drug product under normal conditions of use. Elemental impurities are determined based on methods that are optimized for specific elements in drug product and validated.
To best evaluate your container closure system, West recommends the following approach:
How can West help?
West can provide a variety of services to help aide in your overall risk assessments:
What are the known implementation dates for ICH Q3D?
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.