About this document
CTD Analytical Submission by regulatoryofficer236 is a document available to read on EtoBox.
The document outlines the analytical procedures and validation information for HPLC methods, detailing method specifics such as column type, mobile phase, detector settings, and quantification methods. It includes validation summaries covering analytes, retention times, specificity, accuracy, precision, limits of detection and quantitation, and robustness. Additionally, it mentions the companies responsible for method validation and references typical chromatograms or spectra.
- Author
- regulatoryofficer236
- Language
- EN