---
type: "WebPage"
title: "Impurity analysis and testing at FILAB Laboratory"
description: "Your needs : to identify and characterize an impurity found in a material or in a formulation What is impurity analysis? Impurity analysis is the process of detecting, identifying and quantifying unwanted substances in raw materials, intermediates or finished products. In..."
resource: "https://filab.fr/en/our-services/our-analysis-services/laboratory-detection-identification-impurities/"
tags: ["EN", "pll_610d023268f98", "Anaïs DECAUX"]
timestamp: "2026-05-26T11:48:32Z"
published: "2021-08-06T09:45:55Z"
language: "en"
author: "bwa"
---

# Impurity analysis and testing at FILAB Laboratory

## Your needs : to identify and characterize an impurity found in a material or in a formulation

### What is impurity analysis?

Impurity analysis is the process of detecting, identifying and quantifying unwanted substances in raw materials, intermediates or finished products. 

In pharmaceutical manufacturing, even trace-level impurities can compromise drug safety, trigger regulatory rejection and damage brand reputation.

  Prestations
## Analyse chimique

 Organic impurities
starting materials, by-products, degradation products and reagents

 Inorganic impurities
catalyst residues, heavy metals and environmental contaminants

 Residual solvents
volatile organic chemicals left over from synthesis or purification

 Elemental impurities
 arsenic, cadmium, lead, mercury and other toxic metals regulated by ICH Q3D

### Add Your Heading Text Here

The behavior of an industrial substance is directly linked to the characteristics and the purity of the materials used to produce it. In light of this, monitoring the conformity of the materials being used is a key step of the production process.

The presence of [particulate](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-particulate-contaminant.md) matter, of an unknown [deposit](https://filab.fr/nos-prestations/expertise/laboratoire-analyse-depot-pollution.md), the appearance of [unknown spikes](https://filab.fr/en/laboratory-mass-spectrometry-unknown-spike-analysis.md), etc. These represent cases of non-conformities which can stop a product from going on the market. For this reason, industrialists regularly call on analytical laboratories to identify and characterize any impurities found to be in their materials or formulations.  

## Our solution : to provide you with our skills and our analytical tools, adapting them to your impurity related challenges

With an [analytical fleet spread over 5200m²](https://filab.fr/nos-moyens-techniques.md) and a team made up of doctors and engineers, [FILAB](https://filab.fr/) can assist industrialists in detecting and identifying impurities in their products.

To overcome these challenges with precise and reliable results, FILAB offers a wide range of analytical techniques, adapted to all types of materials :

### Detecting and identifying impurities using a Scanning Electron Microscope coupled to an EDX probe :

[Pollutant identification](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination.md) (embedded particulates)

Search for residual pollutants (lubricants, cleaning residue…)

Surface defect and [adhesive problem characterization](https://filab.fr/en/our-services/rd/problem-solving-related-research-and-development/support-in-solving-your-material-adhesion-problems.md)

Study of ageing materials  

### Detecting and identifying impurities using ICP-AES, ICP-MS and ISP-SEO

[ Contaminant analysis](https://filab.fr/en/our-technical-resources/laboratory-analysis-sem-scanning-electron-microscopy/laboratory-analysis-contaminants.md)

Impurity identification (particulate matter, unknown deposits...)

[Heavy metal analysis](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-heavy-metal.md)

Heavy metal quantification

[Precious metal](https://filab.fr/en/our-services/our-analysis-services/metallurgical-analysis-laboratory/laboratory-analysis-precious-metals.md) analysis

Determination of [trace residues](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-failures/laboratory-analysis-trace-chemicals.md)

### Detecting and identifying impurities using GC-FID, GCMS and UPLC MS/MS :

Search for and quantification of contaminants (residual solvents, pesticides, allergens…)

Determination of [Melamine](https://filab.fr/en/our-services/our-analysis-services/laboratory-detection-identification-impurities.md)

Determination of [phthalates and of DEHP](https://filab.fr/en/our-services/our-analysis-services/chemical-analysis-laboratory/analysis-and-determination-of-phthalates-in-the-laboratory.md)

Determination of [residual solvents](https://filab.fr/en/our-services/our-analysis-services/voc-analysis-laboratory.md)

[Determination of BTEX](https://filab.fr/en/our-services/our-analysis-services/chemical-analysis-laboratory/laboratory-analysis-btex.md)

Validation of cleaning procedures

Determination of [THCs](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-thc-toc.md)

[Determination of Dimethyl fumarate](https://filab.fr/en/our-services/our-analysis-services/laboratory-detection-identification-impurities.md)

Determination of [Bisphenol A](https://filab.fr/en/our-services/our-analysis-services/chemical-analysis-laboratory/bisphenol-analysis-laboratory.md)

[Determination of Formaldehyde](https://filab.fr/en/our-services/our-analysis-services/chemical-analysis-laboratory/laboratory-analysis-formaldehyde.md)

[Determination of VOCs](https://filab.fr/en/our-services/our-analysis-services/voc-analysis-laboratory.md)

[Determination of HAP](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/hap-powder-characterization.md)

D4/D5 analysis

### Detecting and identifying impurities using NMR :

Analysis of active ingredients

Measurement of enantiomeric excess

Measurement of optical purity

### Detecting and identifying impurities in accordance with the European Pharmacopoeia :

Analysis and determination of heavy metals

Analysis of active ingredients

## FILAB detects and identifies impurities in accordance with the relevant regulations :

[PMUC analysis and quality control](https://filab.fr/en/our-services/our-analysis-services/pmuc-analysis/pmuc-controls-laboratory.md)

[Determination of extractables](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/extractable-leachable-analysis/)

[XRD](https://filab.fr/en/our-technical-resources/x-ray-crystallography-laboratory-xrd/analysis-and-characterization-of-materials-by-x-ray-diffraction-xrd-in-the-laboratory/) phase identification et quantification

Migration testing

[Validation of cleaning procedures](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination/validation-of-cleaning-processes-for-the-pharmaceutical-industry.md)

Oxyapatite detction

FILAB has been [CIR (Crédit Impôt Recherche](https://filab.fr/blog/2017/10/laboratoire-agree-cir.md)) approved to be able to provide the best possible assistance.

With three levels of services – analysis, expertise and R&D support – FILAB assists companies from all sectors and of all sizes in overcoming their industrial challenges by sharing its technical know-how and the wealth of experience of its team with its clients.

## FAQ

 Why perform an impurity analysis?
Impurity analysis is a crucial step in the development and manufacturing process of any material or formulation. Impurities can be present at different levels and can come from different sources, such as raw materials, reagents, solvents, water, production environment... These impurities can affect the quality, safety and efficiency of the final product.

Impurity analysis is used to detect and quantify impurities in a material or formulation. The results of this analysis can be used to determine whether the levels of impurities are within regulatory and quality control standards, and whether they are acceptable for the safe and effective use of the product.

Impurity analysis is essential to ensure the quality and safety of pharmaceutical, cosmetic, food and other products. It is also important for optimising manufacturing processes and minimising the risk of cross-contamination during production.

 What is elemental impurity analysis?
In impurity analysis, elemental impurities are substances that contain chemical elements different from those present in the main substance. These impurities may be introduced into a material or formulation from the raw materials or reagents used in the manufacturing process. Elemental impurities may be present in trace amounts, but they can have a significant impact on the quality and performance of the final product.

Elemental impurity analysis is a commonly used technique for quantifying foreign elements in a material or formulation. This analysis can be performed using techniques such as atomic emission spectroscopy, mass spectroscopy, ion chromatography, X-ray fluorescence, etc. The results of this analysis are used to determine the quantity and nature of the elements present in the material or formulation, and to check whether they comply with regulatory and quality control specifications.

 What are the regulations regarding impurity analysis?
There are several regulations in place regarding impurity analysis, depending on the industry and country. Some examples are listed below:

Pharmaceutical industries: European Medicines Agency (EMA) and US Food and Drug Administration (FDA) regulations require drug manufacturers to perform impurity testing to ensure that impurity levels in finished products meet regulatory specifications. International Standards Organisation (ISO) standards are also used to ensure the quality and safety of pharmaceutical products.
Cosmetic industries: European Union (EU) and FDA regulations require cosmetic manufacturers to perform impurity testing to ensure that finished products are free of contaminants and substances harmful to the skin.
Chemical industries: EU and US government regulations require chemical manufacturers to perform impurity testing to ensure that they do not contain substances that are hazardous to the environment or human health.

 Which analytical techniques does FILAB use for elemental impurities testing?
For elemental impurities testing, FILAB primarily uses ICP-AES and ICP-MS, with Single Particle ICP-MS (SP-ICP-MS) for nano-scale elemental detection. These techniques comply with ICH Q3D and USP 232/233 requirements, delivering quantitative data with detection limits down to parts per billion.

 Can FILAB perform impurity analysis according to the European Pharmacopoeia?
Yes. FILAB is experienced in performing impurity analysis in accordance with European Pharmacopoeia monographs, including general chapters on elemental impurities, residual solvents and microbiological contamination. Our COFRAC ISO 17025 accreditation covers many of the methods used, ensuring data integrity and regulatory acceptance.