With a growing global population and health-care market, the consumption of medication has been rapidly rising. As a result, it is now more important than ever to control impurities, including elemental contaminants, when developing pharmaceutical products.
To provide sufficient information about the potential toxicity of inorganic contaminants, new performance-based methods have now been developed for determining elemental impurities in pharmaceutical products:
- ICH (The International Council for Harmonization) Q3D (guidelines)
- USP <232> (limits)
- USP <233> (procedures)
What are pharmaceutical impurities?
Pharmaceutical impurities are unwanted chemicals that remain within active pharmaceutical ingredients (APIs) or drug product formulations.
Where do they come from?
Impurities can come from various sources and include starting materials, intermediaries, reagents, solvents, and reaction by-products.
Why do they need controlling?
The number of various impurities found in drug substances will determine the ultimate safety of the final pharmaceutical product. The overall goal of the new legislation is to keep the consumer safe.
These new methods for elemental impurities testing look to address the limitations of the archaic previous chapters by:
- Extending the list of analytes included
- Reducing the maximum permissible daily exposure (PDE) levels
- Taking account of the route of exposure (e.g., oral, parental, and inhalational)
The new methods recommend ICP-MS and ICP-OES as reference analytical methods. Both offer excellent proficiency for determining inorganic contaminants in accordance with the requirements of ICH Q3D and USP <233>.
Reducing room for errors
Using premade chemical standards eliminates the need for analysts to prepare their own, which reduces preparation time, while minimizing errors. Using chemical reference materials (CRMs) improves accuracy, establishes traceability, and allows quantification of the measurement of uncertainty.
The latest Agilent ICH Q3D/USP <233> Elemental Impurities Kit consists of five CRMs that sort elements by ICH/USP class, chemical compatibility, and the relative mandated concentrations. These kits provide the perfect range of CRMs to meet the method’s PDE levels required. Agilent is the only supplier to provide a full portfolio of standards.
Along with the impurities kit, Agilent also offers a complete solution to support transition to the new methods for elemental impurities in pharmaceuticals.
For Research Use Only. Not for use in diagnostic procedures.