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Data Validation

Data Validation

Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:

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Environmental Engineering
Air Pollution Modelling And Control
Assessing Plastic Waste Associated With Lc-ms/ms Method Validation Procedures.

Home
Research Domains
Engineering
Environmental Engineering
Air Pollution Modelling And Control
Assessing Plastic Waste Associated With Lc-ms/ms Method Validation Procedures.

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Assessing plastic waste associated with LC-MS/MS method validation procedures.

Romain Beziat^1,2, Chan Laurent-Britel¹, Samuel Huguet¹

¹Department of Pharmacologie, Institut Curie, PSL Research University, Saint-Cloud, F- 92210, France.

Cancer Chemotherapy and Pharmacology

|November 21, 2025

View abstract on PubMed

Summary

This summary is machine-generated.

Laboratory diagnostics contribute significantly to climate change. This study quantified plastic waste from validating a tamoxifen LC-MS/MS method, finding daily waste exceeded EU per capita levels, suggesting potential reductions in stability studies.

Keywords:

Bioanalytical method validation Greenhouse gas emissions Plastic waste Tamoxifen

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Area of Science:

Environmental Science
Clinical Chemistry
Pharmaceutical Analysis

Background:

The healthcare sector, particularly laboratory diagnostics, is a significant contributor to greenhouse gas emissions (8-10% in France).
Method validation processes in diagnostics generate substantial plastic waste, impacting environmental sustainability.

Purpose of the Study:

To assess the plastic waste generated during the validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.
To quantify the environmental burden of plastic consumables used in pharmaceutical analysis method validation.

Main Methods:

Plastic consumables were collected throughout the LC-MS/MS method validation process.
Waste was weighed to determine the total plastic burden, following ICH M10 guidelines.

Method performance was evaluated for linearity, accuracy, precision, carry-over, recovery, stability, and robustness.

Main Results:

The LC-MS/MS method met EMA/ICH acceptance criteria for linearity, accuracy, precision, and robustness.
Plastic waste generated during the 39-day validation totaled 5.7 kg (approximately 146 g/day).
This daily waste output was ~1.5 times the average per capita plastic consumption in the EU.

Conclusions:

Method validation for tamoxifen and endoxifen monitoring produced significant plastic waste.
There is potential to reduce plastic waste by optimizing or eliminating certain stability studies, particularly those under controlled conditions.
Sustainable practices in laboratory diagnostics are crucial to mitigate environmental impact.