USP Capillary Electrophoresis Leachables Testing
The USP Chapter 23 and its associated leachables testing provide a framework for ensuring that drug products are safe from potentially harmful substances. Leachables refer to the chemicals that can migrate from packaging materials, containers, and closures into pharmaceutical products during manufacturing processes or storage conditions.
USP's capillary electrophoresis method is highly sensitive and precise, making it ideal for detecting trace amounts of leachable compounds. This service ensures compliance with USP 23-16M, which requires the identification and quantification of leachables from various packaging components. The testing process involves several critical steps:
- Sample preparation: Materials are carefully selected based on their potential to interact with the drug product.
- Extraction: Various solvents are used depending on the material type, ensuring all possible interactions are accounted for.
- Injection and separation: Capillary electrophoresis separates leachables into individual components using a high-voltage electric field.
- Detection and quantification: A photodiode array detector identifies each component by its unique absorption spectrum.
The process is meticulously designed to ensure accurate identification of all relevant compounds, including those at trace levels. This thorough approach helps pharmaceutical companies maintain product integrity and safety throughout the supply chain.
Our laboratory adheres strictly to USP guidelines for method validation, which includes linearity, precision, accuracy, robustness, specificity, and耐用了
