Matrix Effects

USGS scientist operating a high-performance liquid chromatography (HPLC) system in a laboratory

Bioanalytical HPLC Method Development: ICH M10 Practical Guide

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Bioanalytical HPLC method development creates a fit-for-purpose procedure to measure a drug, metabolite or biomarker in a defined biological matrix. For nonclinical and clinical drug studies, the FDA-adopted ICH M10 guideline provides harmonised recommendations for method validation and study-sample analysis. This practical guide outlines how to define the assay, develop sample preparation and chromatography, validate […]

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HPLC detector equipment in a pharmaceutical quality-control laboratory

HPLC Method Development for Food and Beverage Analysis: Practical Guide

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HPLC method development for food and beverage analysis starts with a defined analyte, food matrix and decision the result must support. A method for vitamins in juice may not be suitable for preservatives in soft drinks or contaminants in oils. This practical guide covers analytical goals, sample preparation, chromatographic conditions, validation, quality control and regulatory

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USGS scientist operating a high-performance liquid chromatography (HPLC) system in a laboratory

HPLC Method Development for Environmental Analysis: Practical Guide

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HPLC method development for environmental analysis begins with a defined analyte, sample matrix and decision the data must support. A fit-for-purpose method can measure selected organic contaminants in water, soil, sediment or wastewater, but no single HPLC method detects every pollutant. This guide explains how environmental laboratories plan sample handling, separation, detection and quality controls

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