According to this guideline, by the end of 2017, finished medicinal products must be subjected to a risk analysis in order to assess the possible presence of metallic impurities. The guideline incorporates 24 elements, which are divided into 4 risk groups according to their toxicity. The resulting thresholds for the products arise from the so-called PDEs (permitted daily exposure), which depend on the medicinal product’s form of dosage (oral, parenteral, inhaled). In order to carry out the relevant risk analysis, the first step is an element screening involving an appropriate procedure for establishing the exposure situation for the products concerned. Depending on the result, the potential pathways for risky elements (for example process auxiliaries, catalysts, process water or packaging) must be taken into consideration, and appropriate measures for reducing them must be taken.
For this purpose, we have developed a standardised screening method that has already been implemented with success. The technology is based on the combination of microwave-aided acidulation with an ICP-MS measurement (mass spectrometry with inductively coupled plasma), and we have validated it with various finished medicinal products (tablets, capsules). And of course, the analysis is carried out and documented in accordance with GMP. You also receive a detailed test report.
The Institut Kirchhoff GmbH helps you implement this guideline with the following services:
- Assistance with developing a concept for implementing the Q3D
- Product-specific method validation for determining the elemental impurities
- Analysis using sensitive and qualified ICP-MS and ICP-OES equipment systems.
- Determination of the control strategy for continuous product analyses
We would be pleased to provide you with an appropriate quotation.
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