UPLC Assay and Purity Testing
The UPLC (Ultra Performance Liquid Chromatography) Assay and Purity Testing service offered by Eurolab is a cornerstone of pharmaceutical quality control. This advanced analytical technique provides highly sensitive, precise, and rapid analysis of active pharmaceutical ingredients (APIs), excipients, and final drug products.
UPLC technology enables the separation of complex mixtures with unprecedented resolution in shorter time frames compared to traditional HPLC methods. The use of smaller particle columns and high-pressure gradients allows for faster separations without compromising on peak capacity or resolution.
The assay process involves a series of steps designed to ensure accurate quantification of active components within pharmaceutical formulations. This includes sample preparation, injection into the UPLC system, and subsequent analysis via mass spectrometry (MS) or photodiode array detectors (PDAD). The primary objective is to determine the concentration levels of the API as well as any impurities present.
Purity testing focuses on identifying and quantifying both major and minor impurities within a drug substance. These impurities may arise from manufacturing processes, degradation products, or residual solvents. By conducting thorough purity assessments early in development stages, manufacturers can mitigate risks associated with potential side effects during clinical trials and post-market surveillance.
Our UPLC Assay and Purity Testing service adheres strictly to international standards such as USP 871, ICH Q5D, and EU guidelines. These regulatory frameworks provide clear parameters for acceptable limits of impurities in drug products. Our team employs state-of-the-art instrumentation from reputable manufacturers like Waters Corporation and Shimadzu Corporation to ensure consistent results across all analyses.
Sample preparation plays a critical role in achieving reliable UPLC Assay outcomes. Properly prepared samples minimize matrix effects that could interfere with accurate detection of analytes. Common sample handling procedures include dissolution, filtration, dilution, or derivatization depending on the nature of the compound being analyzed.
- Sample preparation: Ensures consistent and reproducible results by minimizing potential interferences from excipients or other components within the formulation.
- Injection method: Using appropriate injection volumes helps optimize chromatographic performance while maintaining sensitivity throughout the entire range of concentrations expected in real-world samples.
- Data interpretation: Advanced software tools assist analysts in interpreting complex data sets generated by UPLC systems, enabling accurate quantification and identification of even trace amounts of impurities.
To sum up, our comprehensive UPLC Assay and Purity Testing service offers pharmaceutical companies the assurance they need regarding product quality. By leveraging cutting-edge technology combined with rigorous adherence to best practices outlined by regulatory bodies worldwide, we deliver reliable data that supports informed decision-making throughout drug development cycles.
Eurolab Advantages
EuroLab prides itself on being your partner in excellence when it comes to pharmaceutical testing services. Our team of highly skilled scientists and engineers brings extensive experience across various sectors including healthcare, cosmetics, food & beverage, petrochemicals, and electronics manufacturing.
- State-of-the-art facilities: We house some of the most sophisticated analytical instruments available today, ensuring accurate measurements down to parts per billion (ppb) levels. This level of precision is essential for detecting trace amounts of impurities that might otherwise go undetected using less advanced techniques.
- Comprehensive expertise: Our multidisciplinary approach allows us to cater to diverse client needs ranging from simple quality control checks to complex custom analysis projects tailored specifically to meet individual business requirements.
- ISO 17025 accreditation: We maintain strict adherence to ISO/IEC standards which guarantee impartiality, competence, and integrity in our laboratory operations. This accreditation assures clients that they are receiving services from a reputable institution recognized globally for its reliability and accuracy.
- On-time delivery: With efficient workflows optimized through years of experience, we ensure timely completion of all assigned tasks without compromising on quality standards. Reliable turnaround times enable seamless integration into busy R&D schedules or production timelines.
Beyond just providing robust analytical capabilities, EuroLab also offers valuable insights based on our deep understanding of industry trends and regulatory expectations. Our clients benefit from strategic advice that helps them stay ahead in today's competitive marketplace.
Quality and Reliability Assurance
EuroLab is committed to maintaining the highest levels of quality assurance throughout every stage of our UPLC Assay & Purity Testing service. From initial consultation through final report generation, we follow strict protocols designed to minimize errors while maximizing efficiency.
The process begins with thorough client consultations where detailed information about the sample characteristics and desired outcomes are gathered. This ensures that all subsequent testing activities align perfectly with specific project goals. Once agreed upon, samples undergo rigorous validation procedures prior to actual analysis taking place in our certified laboratories.
During analysis itself, multiple checks are performed at various stages including calibration of instruments, verification of reagents used, and confirmation of method performance parameters such as linearity, precision, accuracy, and robustness. These steps guarantee that all results obtained meet or exceed specified tolerances set forth by relevant regulatory bodies.
Post-analysis, comprehensive reports are generated detailing key findings along with supporting graphical representations where applicable. Each report undergoes final review by senior members of our scientific team before being issued to clients. This ensures that only thoroughly vetted information makes its way into your hands ensuring complete confidence in the accuracy and reliability of each result presented.
By adhering strictly to international standards like USP 871, ICH Q5D, and EU guidelines during all aspects of our service delivery, EuroLab maintains unwavering commitment towards delivering accurate, reliable data that can be trusted implicitly by all stakeholders involved in pharmaceutical development processes.
