Method Development, Validation & Transfer
Chemical analysis
Microbiological analysis
At QNTM Labs, method development validation encompasses both chemical and microbiological analyses. With a robust foundation in research and development (R&D), our team brings extensive experience and innovation to each project. We specialize in creating and optimizing analytical methods tailored to raw materials, active pharmaceutical ingredients (APIs), and finished products, ensuring they meet rigorous standards for accuracy, effectiveness, and regulatory compliance.
Method Development
Advanced Analytical Techniques: Expertise in HPLC, UPLC, GC, GC-MS, LC-MS, and ICP-MS for chemical analysis, as well as approaches for microbiological determinations such as cell count.
Custom Method Development: Tailoring methods to specific client needs, from raw materials to finished products, ensuring precise detection and quantification.
Optimization of Existing Methods: Enhancing the performance of supplied methods to achieve better efficiency, sensitivity, and specificity.
Method Validation
Comprehensive Validation Studies: Our validation processes cover all critical parameters, adhering to ICH guidelines or according to clients' specifications to ensure method reliability across diverse applications.
Specificity: Confirm that the method discriminatively assesses the analyte in the presence of other components, such as impurities, degradants, and matrix components.
Linearity and Range: Demonstrating that the method provides consistent results within a given range.
Accuracy and Precision: Ensuring the method produces results close to the actual value and consistently reproducible.
Repeatability and Intermediate Precision: Testing the method's consistency within the same laboratory and under variable conditions.
Detection and Quantitation Limits: Establishing the minimum levels at which the analyte can be reliably detected and quantitatively measured.
Robustness: Evaluating the method's reliability under a variety of operational conditions.
Method Transfer
Protocol Development and Documentation: Creating detailed protocols and documentation to ensure seamless method transfer between sites or labs.
Cross-Site Implementation and Validation: Facilitating and verifying method performance across multiple locations to ensure uniformity and compliance.
Ongoing Technical Support: Providing continuous support and troubleshooting to maintain method performance and adapt to new challenges.
QNTM Labs is dedicated to high quality, timely delivery, and complete transparency throughout the process. We look forward to working as an extended part of your internal QC team.