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Related Concept Videos

Development of Analytical Methods01:21

Development of Analytical Methods

An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
Sample Preparation for Analysis: Overview01:21

Sample Preparation for Analysis: Overview

Sample preparation is an essential step in the analytical process. It involves preparing a sample so that it can be analyzed accurately. The goal is to extract the analyte, the substance you want to measure, from the sample while removing any components that may interfere with the analysis. Sample preparation techniques vary depending on the physical state of the sample.
Bulk or large solid samples are typically reduced in size using grinding, crushing, or milling techniques to increase the...
Quantitative Analysis01:12

Quantitative Analysis

Quantitative analysis is a technique for measuring the amount of specific constituents in a sample. When the sample's composition is unknown, qualitative analysis is performed first to identify its components, which ensures that the correct substances are measured during the quantitative phase.
In quantitative analysis, two key measurements are made: the sample quantity and a property proportional to the amount of the analyte (the substance being analyzed). This forms the basis of the method...
Blank Solutions00:56

Blank Solutions

A blank solution is a solution that does not contain the analyte, or the substance of interest being tested or measured. It is typically prepared using the same reagents and procedure as the sample solution but without adding the analyte. The primary purpose of preparing a blank solution is to account for any background interference or contamination that may affect the accuracy and reliability of the analytical method.
In some experimental cases, the reagents, solvents, or lab equipment used in...
Sample Handling01:02

Sample Handling

Transportation of samples from the collection point to the laboratory, as well as storage and preservation techniques, are crucial for maintaining sample integrity and ensuring accurate and reliable test results.
Samples should be transported carefully from collection points to the laboratory. They should be properly sealed and clearly labeled to prevent cross-contamination. To preserve the sample integrity, optimal temperature conditions during transport are essential. This could involve using...
Sample Preparation for Analysis: Advanced Techniques01:08

Sample Preparation for Analysis: Advanced Techniques

Accurate analysis of complex samples often requires advanced preparation techniques to achieve reliable and reproducible results. Samples containing inorganic or organic materials can be challenging to dissolve or decompose effectively. Standard sample preparation methods include acid digestion, fusion, dry ashing, and wet digestion.
Acid digestion with strong acids is commonly used to dissolve inorganic materials that are insoluble (do not dissolve) in water. This method can be useful for...

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Related Experiment Video

Updated: May 8, 2026

Untargeted Metabolomics from Biological Sources Using Ultraperformance Liquid Chromatography-High Resolution Mass Spectrometry (UPLC-HRMS)
11:00

Untargeted Metabolomics from Biological Sources Using Ultraperformance Liquid Chromatography-High Resolution Mass Spectrometry (UPLC-HRMS)

Published on: May 20, 2013

The transfer of analytical procedures.

J Ermer1, M Limberger, K Lis

  • 1Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.

Journal of Pharmaceutical and Biomedical Analysis
|August 28, 2013
PubMed
Summary

Successful analytical method transfer in GMP requires clear communication and scientifically sound evaluation. Equivalence tests are recommended over significance tests for robust results, ensuring analytical relevance.

Keywords:
Absolute acceptance criteriaAnalyticalEquivalence testMethod transferSuccess factor

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Regulatory Affairs

Background:

  • Analytical method transfer is critical in the GMP sector but lacks detailed regulation.
  • Guidelines from USP, WHO, ISPE, and the EU GMP draft highlight its importance.
  • Effective communication between sending and receiving units is key to successful transfers.

Purpose of the Study:

  • To provide an overview and comparison of existing analytical transfer guidelines.
  • To offer practical tools like procedures, flow charts, and checklists for facilitating method transfers.
  • To detail and compare statistical strategies for evaluating transfer success.

Main Methods:

  • Comparative analysis of major regulatory guidelines (USP, WHO, ISPE, EU GMP).
  • Development of practical aids: procedures, flow charts, checklists, glossary.
  • In-depth description and comparison of statistical tools: significance tests, absolute criteria, equivalence tests.

Main Results:

  • Significance tests should be avoided; analytical relevance is the true success criterion.
  • Equivalence tests are recommended for higher-risk procedures due to their inclusion of practical limits and risk control.
  • Absolute acceptance criteria are sufficient for lower-risk procedures.

Conclusions:

  • Excellent communication and scientifically sound evaluation with appropriate acceptance criteria are crucial for efficient and sustainable analytical procedure transfer.
  • Risk assessment should guide the choice of statistical strategy, favoring equivalence tests for robust validation.
  • Practical tools and clear procedures enhance the transfer process and minimize potential pitfalls.