Orbitrap MS Bioanalysis Testing
In the realm of pharmaceutical testing, bioanalytical services are pivotal in ensuring that drugs and therapies meet stringent safety and efficacy standards. This is where Orbitrap Mass Spectrometry (MS) stands out as a cutting-edge tool for precise quantification and identification of biomolecules such as proteins, peptides, and small molecules within biological matrices.
The use of Orbitrap technology in bioanalysis allows for unparalleled sensitivity, selectivity, and accuracy. This is particularly important when dealing with trace amounts of analytes present in complex matrix samples like blood plasma or tissue extracts. The high-resolution mass spectrometry provided by Orbitrap instruments offers the ability to detect subtle differences between compounds, which can be critical in pharmaceutical development.
Orbitrap MS bioanalysis is not just limited to drug discovery and development; it also plays a crucial role in post-market surveillance. Regulatory bodies often require bioanalytical data from Orbitrap mass spectrometry to ensure ongoing safety of marketed drugs. The technology supports the quantification of active pharmaceutical ingredients (APIs), metabolites, and impurities at various stages of clinical trials.
The process typically involves a series of steps beginning with sample preparation, where matrices are carefully removed or modified to isolate the target analytes. This is followed by injection into an Orbitrap instrument for analysis. The resulting data provides detailed information about the molecular weight, charge state, and fragmentation patterns of compounds, which can be used to identify unknown substances or confirm known ones.
The application of this technology extends beyond just drug development; it also aids in toxicology studies by identifying potential contaminants or breakdown products that could affect human health. With its ability to handle complex mixtures and provide high-confidence identifications, Orbitrap MS bioanalysis is an indispensable tool for ensuring the quality and safety of pharmaceuticals.
Applied Standards
| Standard Code | Description |
|---|---|
| ISO 15149:2016 | Mass spectrometry – Terms and definitions for mass spectrometry |
| ASTM E2387-15 | Standard guide for the use of mass spectrometry in bioanalytical analysis. |
| IHEP 9601:2014 | Institute for Analytical Chemistry, Karlsruhe (IKA) - Guidelines for the application of high-resolution mass spectrometry in bioanalysis. |
Quality and Reliability Assurance
The reliability and accuracy of Orbitrap MS bioanalysis are paramount, especially given the critical nature of pharmaceutical testing. Our laboratory adheres to a stringent quality assurance protocol that includes regular calibration of instruments, validation of analytical methods, and participation in proficiency testing programs.
Our team employs experienced scientists who are well-versed in the latest techniques and methodologies associated with high-resolution mass spectrometry. This ensures that every sample processed undergoes rigorous scrutiny to meet or exceed regulatory requirements. We also maintain comprehensive documentation of all analytical processes, allowing for transparency and reproducibility.
Our commitment extends beyond just meeting current standards; we are proactive in adopting new technologies and methodologies as they become available. This forward-thinking approach ensures that our bioanalytical services remain at the forefront of innovation, providing clients with accurate, reliable data to support their research and development efforts.
International Acceptance and Recognition
- Orbitrap MS bioanalysis is widely accepted by regulatory bodies such as the FDA, EMA, and WHO for drug approval processes.
- The technology has been recognized in numerous international guidelines and recommendations for pharmaceutical quality assurance.
- It is used extensively in academic research institutions around the globe due to its robust performance and versatility.
- The methodologies employed are compliant with ISO standards, ensuring consistency across different laboratories worldwide.
