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Apurun

Net Charge or Zeta Potential

Net Charge or Zeta Potential

Regular price $940.00 USD
Regular price Sale price $940.00 USD
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Apurun's services for testing, methods development, and validations for net charge or zeta potential quality controls of lipid nanoparticles (LNPs) and liposomal drug products align with FDA guidelines to ensure compliance and product safety. Here's how Apurun's offerings correspond to FDA guidelines: 1) Methods Development: Apurun collaborates with pharmaceutical companies to develop robust methods for measuring net charge or zeta potential of LNPs and liposomal formulations. These methods are designed to be sensitive, specific, accurate, and reproducible, meeting the requirements outlined in FDA guidelines for analytical method development. 2) Method Validation: Apurun validates the developed methods according to FDA guidelines for analytical method validation. This involves conducting validation studies to demonstrate the reliability and suitability of the methods for their intended use. Parameters such as accuracy, precision, specificity, linearity, and robustness are evaluated to ensure the validity of the analytical results. 3) Testing Services: Apurun offers testing services for net charge or zeta potential measurements of LNPs and liposomal drug products. These tests are conducted using validated methods and protocols, 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 timely assessments of net charge or zeta potential as per FDA guidelines. By monitoring these critical parameters, Apurun helps pharmaceutical companies maintain the quality, consistency, and stability of their products throughout the manufacturing process and product lifecycle. 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 net charge or zeta potential measurements meet regulatory requirements and contribute to the safety and efficacy of LNPs and liposomal formulations. In summary, Apurun's comprehensive services for testing, methods development, and validations for net charge or zeta potential quality controls of LNPs and liposomal drug products are in line with FDA guidelines. 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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