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High-Performance Liquid Chromatography (HPLC)

High-Performance Liquid Chromatography (HPLC)

Regular price $475.00 USD
Regular price $650.00 USD Sale price $475.00 USD
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Apurun's services for testing, method development, and validations for High-Performance Liquid Chromatography (HPLC) purity and composition characterization align with FDA guidelines for quality controls of lipid nanoparticles (LNPs) and liposomal drug products. Here's how Apurun's offerings correspond to FDA guidelines: 1) Methods Development: Apurun collaborates with pharmaceutical companies to develop robust HPLC methods for the purity and composition characterization of LNPs and liposomal formulations. These methods are designed to accurately separate and quantify individual components such as lipids, drugs, and impurities, in accordance with FDA guidelines for analytical method development. 2) Method Validation: Apurun validates the developed HPLC methods following FDA guidelines for analytical method validation. This involves conducting validation studies to demonstrate the reliability, accuracy, precision, specificity, and robustness of the methods for their intended use in characterizing LNPs and liposomal drug products. 3) Testing Services: Apurun offers testing services using validated HPLC methods for purity and composition characterization of LNPs and liposomal formulations. These tests are performed according to established protocols and standards, ensuring that the results are consistent, reliable, and compliant with FDA requirements. 4) Quality Control: Apurun's testing services contribute to quality control efforts by providing accurate and comprehensive assessments of purity and composition characteristics using HPLC. By monitoring these critical parameters, Apurun helps pharmaceutical companies ensure the quality, consistency, and stability of their products throughout the manufacturing process and product lifecycle, as per FDA guidelines. 5) Regulatory Compliance: Apurun's methods development, validation, and testing services are designed to facilitate regulatory compliance with FDA guidelines for pharmaceutical products. By adhering to established standards and best practices, Apurun ensures that the HPLC-based purity and composition characterization of LNPs and liposomal formulations meet regulatory requirements and contribute to the safety and efficacy of these products. Apurun's comprehensive services for HPLC purity and composition characterization align with FDA guidelines for quality controls of LNPs and liposomal drug products. By providing accurate, reliable, and compliant analytical solutions, Apurun supports pharmaceutical companies in meeting regulatory requirements and ensuring the quality and safety of their products.



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