Have you ever wondered what lipsticks, paints, and medicines could possibly have in common? Surprisingly, they are all linked by the presence of elemental impurities.
These impurities are microscopic elements that can have significant effects, whether they are in your medicine, your wall paint, or even your makeup.
The ICH Q3D guideline, a pivotal document in the pharmaceutical industry, aims to clarify and reduce these grey areas in medicinal products by establishing a risk-based approach to controlling elemental impurities.
The guideline helps ensure that the impurities present do not pose a toxicological risk to patients, considering the specific route through which a drug is administered.
A Closer Look at ICH Q3D Guideline
The ICH Q3D guideline consists of three main parts:
- Evaluation of Toxicity Data: This part involves assessing the available toxicological data on potential elemental impurities that could be present in drug products.
- Establishment of Permitted Daily Exposure (PDE): For each element of toxicological concern, a PDE value is established, guiding safe exposure levels.
- Risk-Based Control Application: This section advocates for a risk-based strategy to effectively manage and mitigate the presence of elemental impurities.
At Quercus Labo, we specialize in addressing these concerns with a cutting-edge screening method designed to detect elemental contaminants in active ingredients, ancillary materials, and finished medicinal products.
Our method, developed internally, includes a rigorous process combining microwave-assisted acid digestion and mass spectrometry with inductively coupled plasma (ICP-MS), capable of quantitatively analyzing 46 different elements.
Get in Touch for Expert Analysis
- Are you ready to perform a quality control screening on your product?
- Do you have a risk analysis in place, but want to ensure nothing was overlooked?
- Or perhaps you’re looking to implement controls for elemental impurities but are unsure of the specifics?
Contact Quercus Labo today to safeguard your products against elemental impurities with precision and confidence!
