Elemental impurities, includes catalysts and environmental contaminants that may be present in drug substances, excipients, or drug products. These impurities may occur naturally, be added intentionally, or be introduced inadvertently (e.g., by interactions with processing equipment and the container–closure system). When elemental impurities are known to be present, have been added, or have the potential for introduction, assurance of compliance to the specified levels is required.
We Perform Elemental impurities studies for
We provide high throughput approach for routine screening
- Our consolidated scientific solutions ensure customers get streamlined support across functions.
- Our team is well versed and stay up to date with respect to regulatory guidelines and methods. For accurate and reliable results our team works with best-in-class equipment, including ICP-MS systems.
- We have rich experience with elemental impurity testing, including method development, validation, batch analysis and reverse engineering for elemental impurities.
Why Test for Elemental impurities in Drug Products?
The presence of elemental impurities (Class-I, 2A, 2B and 3) in drug products poses a considerable risk to public health. Regulatory agencies worldwide have implemented stringent guidelines and regulations mandating the testing and control of elemental impurity levels in pharmaceuticals. Detecting and quantifying elemental impurities in drug products is crucial for ensuring compliance with regulatory standards and safeguarding patient safety.
Elemental impurities Testing:
Inductively Coupled Plasma-Mass Spectrometry (ICP-MS): ICP-MS is a powerful analytical technique capable of detecting and quantifying trace levels of elemental impurities upto ppb or ppt levels. This technique is widely used in pharmaceutical laboratories for the identification and determination of elemental impurities.
Tests we Perform at our end:
- Elemental impurity testing as per ICH Q3D guidelines.
- Product specific elemental impurity testing as per defined specifications.
- Quantification of Elemental impurities in reverse engineering process.
Regulatory Requirements and Guidelines:
We follow testing as per below mentioned regulatory guidelines.
- ICH Q3D
- USP <232>
- USP <233>
- USP <730>
At Eurofins BioPharma Product Testing (Eurofins BPT) we understand that the elemental impurities testing is a critical aspect of pharmaceutical quality control, aimed at protecting public health by preventing exposure to potential elemental impurities. By implementing robust testing methods and adhering to regulatory guidelines, pharmaceutical companies can mitigate the risk of elemental impurities and ensure the safety and efficacy of their products.
Contact us bd@advinus.eurofinsasia.com to discuss elemental impurity studies for your drug substances and drug products testing.