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Apurun

Gas Chromatography with the Flame Ionization Detector (GC-FID)

Gas Chromatography with the Flame Ionization Detector (GC-FID)

Regular price $940.00 USD
Regular price Sale price $940.00 USD
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Apurun's Services for GC-FID Analysis of Residual Solvents in LNPs and Liposomal Drug Products: 1) Method Development: Apurun collaborates with pharmaceutical companies to develop robust GC-FID methods specifically tailored for residual solvent analysis in LNPs and liposomal drug products. These methods adhere to FDA guidelines, ensuring accuracy and reliability in assessing residual solvent levels. 2) Method Validation: Apurun conducts comprehensive validation studies to demonstrate the accuracy, precision, and robustness of the developed GC-FID methods for residual solvent analysis. This validation process ensures compliance with FDA requirements and instills confidence in the obtained results. 3) Testing Services: Apurun offers testing services utilizing validated GC-FID methods for residual solvent analysis in LNPs and liposomal formulations. These tests provide crucial information regarding the presence and levels of residual solvents, thereby contributing to quality control efforts and ensuring product safety. 4) Quality Control: Apurun's GC-FID testing services play a vital role in quality control by providing accurate assessments of residual solvent contents. Monitoring residual solvent levels helps ensure compliance with regulatory limits and standards, ultimately safeguarding product quality and patient safety. 5) Regulatory Compliance: Apurun's services are designed to align with FDA regulations, facilitating regulatory compliance for pharmaceutical products concerning residual solvent content. By adhering to standardized protocols and best practices, Apurun assists companies in meeting regulatory requirements and obtaining product approvals. Apurun's expertise in GC-FID-based residual solvent analysis supports pharmaceutical companies in ensuring the quality, safety, and regulatory compliance of LNPs and liposomal drug products.

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