Clinical Trial Capillary Electrophoresis Analysis Testing
Capillary electrophoresis (CE) is a powerful analytical technique that has found extensive application in pharmaceutical testing, particularly during clinical trials. This method allows for the separation and quantification of components within complex mixtures such as biologics, small molecule drugs, and other therapeutic agents. In the context of clinical trials, CE plays a crucial role in ensuring drug safety and efficacy by providing accurate quantitation and characterization data.
At Eurolab, we utilize state-of-the-art capillary electrophoresis instrumentation to deliver comprehensive analytical support for your pharmaceutical testing needs during clinical trials. Our services encompass the analysis of various sample types including but not limited to:
- Blood plasma
- Serum
- Urine
- Lymph node aspirates
- Cell culture media
The analytical scope includes identification, quantification, and characterization of active pharmaceutical ingredients (APIs), excipients, metabolites, and impurities. This information is critical for regulatory compliance and ensuring product quality.
To achieve reliable results, our team follows strict protocols that include:
- Sample preparation using validated methods
- Instrument calibration to ensure precision and accuracy
- Method development tailored to the specific requirements of your clinical trial
- Data validation and quality assurance
The process begins with receiving samples, which are then prepared according to the specified protocols. Once prepared, these samples undergo CE analysis on our advanced equipment. The results from this analysis provide detailed insights into the composition and purity of the drug substance or formulation being tested.
Our laboratory adheres to international standards such as ISO/IEC 17025 for quality management systems in testing and calibration laboratories, ensuring that every test we conduct meets the highest industry standards. We also comply with relevant regulatory guidelines including those issued by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other global health authorities.
For more specific information on our analytical capabilities, please refer to the Applied Standards section of this page.
| Standard | Description |
|---|---|
| ISO/IEC 17025:2017 | International standard for the competence of testing and calibration laboratories |
| USP & NF (United States Pharmacopeia) | American pharmacopeial standards recognized worldwide |
Applied Standards
| Standard | Description |
|---|---|
| ISO/IEC 17025:2017 | This standard ensures that our laboratory is capable of conducting tests and providing calibrations according to the requirements specified by customers. It covers all aspects from personnel qualifications, equipment calibration, method validation, sample handling, data management, and reporting. |
| USP & NF (United States Pharmacopeia) | The USP is an official public document that sets standards for medicines and related products to ensure the quality, identity, strength, and purity of pharmaceutical drugs. The National Formulary (NF) provides additional information on drug specifications. |
| ICH Q2B: Chromatographic Method Validation | This guideline ensures that all chromatographic methods used in our laboratory are validated to ensure they meet the required precision, accuracy, and specificity for their intended use. |
| Ph. Eur (European Pharmacopoeia) | The European Pharmacopoeia is a legal document containing standards of identity, purity, and quality for medicinal products in Europe. |
Eurolab Advantages
Our expertise lies not only in the technology but also in our ability to provide customized solutions that meet your specific clinical trial requirements. Our team of experienced scientists and engineers ensures that all tests are conducted with utmost accuracy and precision, providing you with reliable data that can be used for decision-making purposes.
We pride ourselves on delivering timely results while maintaining strict adherence to regulatory guidelines. With our advanced equipment and experienced staff, we offer a range of services from method development to full-service contract testing.
Our commitment to excellence is reflected in our approach to every project, ensuring that you receive the highest quality service possible. Whether you need support with sample preparation or require comprehensive analytical data, Eurolab has the expertise and facilities to deliver exceptional results.
International Acceptance and Recognition
- ISO/IEC 17025:2017: This standard is accepted worldwide by regulatory authorities, ensuring that our laboratory meets the highest international standards for testing and calibration.
- USP & NF (United States Pharmacopeia): Widely recognized in North America and globally, these standards are used as references for quality assurance in pharmaceutical manufacturing.
- Ph. Eur: Accepted by the European Union, this standard is essential for ensuring that medicinal products meet high-quality standards.
- ICH Q2B: Chromatographic Method Validation: This guideline ensures compatibility and acceptance of analytical methods across different laboratories and jurisdictions.
