Silicon Impurity Profiling Testing
In the pharmaceutical industry, ensuring product purity is paramount. Silicon impurities can have a significant impact on drug efficacy and safety. At Eurolab, we offer comprehensive silicon impurity profiling testing services to help our clients ensure their products are free from harmful contaminants.
Our testing process begins with detailed sample preparation. This involves extracting the silicon compounds from the pharmaceutical substance using advanced extraction techniques such as liquid-liquid extraction or solid-phase extraction. Once extracted, these samples undergo rigorous analysis by our state-of-the-art equipment.
The analytical methods used for silicon impurity profiling include but are not limited to inductively coupled plasma mass spectrometry (ICP-MS), high-performance liquid chromatography (HPLC), and gas chromatography coupled with mass spectrometry (GC-MS). These techniques provide precise quantification of trace amounts of silicon, down to the parts per billion level.
Our team of experienced chemists and scientists ensures that every step of the process adheres strictly to international standards such as ISO 17025. This guarantees the reliability and accuracy of our results. The rigorous adherence to these standards also ensures compliance with regulatory requirements like those set forth by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
The significance of this testing cannot be overstated, especially in light of recent recalls due to silicon contamination issues. By proactively identifying and quantifying silicon impurities, pharmaceutical companies can maintain high standards of quality control, thereby protecting consumer health.
| Applied Standards |
|---|
| ISO 17025:2017 – General requirements for the competence of testing and calibration laboratories |
| USP United States Pharmacopeia (USP) |
| Pharmacopoeia of the People's Republic of China |
Applied Standards
- ISO 17025:2017 – General requirements for the competence of testing and calibration laboratories
- USP United States Pharmacopeia (USP)
- Pharmacopoeia of the People's Republic of China
Eurolab Advantages
At Eurolab, we pride ourselves on offering exceptional service and expertise in pharmaceutical testing. Our dedicated team of professionals combines extensive experience with cutting-edge technology to deliver accurate results consistently.
- State-of-the-art laboratory facilities equipped for precise analysis
- Dedicated project managers to ensure seamless communication and support
- Compliance with international standards ensuring reliability and accuracy of results
- Quick turnaround times without compromising on quality
Customer Impact and Satisfaction
Our clients benefit from our rigorous testing procedures, which contribute to maintaining the highest standards in product purity. This not only enhances brand reputation but also ensures compliance with regulatory bodies.
- Enhanced product safety for consumers
- Increased confidence among regulatory agencies regarding product quality
- Improved customer satisfaction due to reduced risk of adverse events
- Cost savings through early detection and resolution of potential issues
