In the pharmaceutical industry, controlling residues and contaminants is a key challenge to ensure product quality, safety, and compliance. Raw materials, active pharmaceutical ingredients (APIs), excipients, finished products, production equipment, or contact materials: many sources can introduce unwanted substances.
Pharmaceutical residues and contaminants: identifying the source of contamination through chemical analysis
Contamination can occur at different stages of the production cycle: receipt of raw materials, synthesis, formulation, packaging, equipment cleaning, or storage.
It may in particular come from:
- solvent or reagent residues;
- degradation products;
- residues from cleaning processes;
- organic or mineral contaminants;
- metal traces;
- substances originating from production equipment;
- packaging materials;
- impurities related to raw materials or excipients;
- cross-contamination between products.
The challenge is therefore not only to detect a substance. It is also necessary to determine its nature, concentration level, and, when possible, its origin in order to guide corrective actions.
Which chemical analysis are used to search for residues and contaminants?
At the FILAB laboratory, the analytical strategy is defined according to the matrix, the contaminant being sought, and the expected level of sensitivity.
Analysis of Organic Contaminants
Chromatographic techniques make it possible to detect and quantify many organic substances present at trace levels.
Depending on the issue at hand, the laboratory can in particular use:
- GC-MS for the identification and quantification of volatile and semi-volatile compounds;
- HPLC for the analysis of non-volatile or heat-sensitive compounds;
- LC-MS/MS for targeted screening of contaminants at low concentrations;
- LC-QTOF or LC-Orbitrap for screening and non-targeted identification approaches;
- FTIR to characterize certain substances or compare a contaminant with a reference.
These approaches can in particular be used to look for solvent residues, organic impurities, degradation products, or material-derived contaminants.
Search for Elemental and Metallic Contaminants
Metal contamination can come from raw materials, equipment, manufacturing processes, or the production environment.
The FILAB laboratory carries out elemental analyses that make it possible to detect and quantify elements present at trace levels, in particular by:
- ICP-MS, for analyses at very low concentrations;
- ICP-OES / ICP-AES, for multi-element quantification;
- SEM-EDX, to locate and characterize particles or inclusions containing specific elements.
These analyses can in particular contribute to the assessment of elemental impurities within the framework of the requirements applicable to pharmaceutical products.
Characterization of an Unknown Contaminant
When an industrial company detects a particle, deposit, discoloration, or unexpected analytical peak without knowing its composition, an identification process can be set up.
The goal is then to progressively answer several questions: What is the contaminant? Where is it located? What is it made of? At what concentration is it present? What could be its origin?
Combining several techniques makes it possible to obtain a more complete characterization: spectroscopy, chromatography, elemental analysis, microscopy, or surface techniques depending on the case.
Analysis of pharmaceutical cleaning residues
Cleaning process validation requires demonstrating that residues of products, active ingredients, excipients, or cleaning agents are under control after equipment cleaning.
The FILAB laboratory can support manufacturers in setting up suitable methods for the detection and quantification of these residues.
The analytical approach depends in particular on:
- the chemical nature of the product being sought;
- the matrix being analyzed;
- the expected detection or quantification limit;
- the type of equipment involved;
- the sampling method selected.
The analysis can therefore help document cleaning control and the prevention of cross-contamination.
Residues and contaminants: going as far as identifying the root cause
Simple detection is not always enough to solve an industrial issue.
When a contaminant is found, the challenge may be to understand how it got into the product.
The FILAB laboratory can then step in with an analytical expertise approach: comparison of compliant and non-compliant samples, analysis of raw materials, characterization of particles or deposits, search for metallic traces, analysis of degradation products, or investigation of different elements of the process.
Why Choose the Filab Laboratory for the Chemical Analysis of Residues and Contaminants?
An independent French laboratory based in Dijon, FILAB combines more than 30 years of expertise in analytical chemistry with in-depth knowledge of the pharmaceutical sector's requirements.
- State-of-the-art analytical equipment: a 5,200 m² technical platform equipped with the most sensitive technologies (ICP-MS, LC-MS/MS, GC-MS, Headspace GC-FID) capable of detecting traces down to the ppb level.
Dual expertise in Chemistry and Materials: a unique ability to handle both the quantification of chemical contaminants (nitrosamines, solvents) and packaging impact (Extractables & Leachables studies, particle characterization).
Responsiveness and tailor-made support: no generic answers. A chemistry PhD or a dedicated engineer manages your project, from tailor-made method development (ICH Q2) to urgent analysis for batch release.
Our FAQ
To get a quote from FILAB laboratory, you can contact our teams via our contact form, by phone, or by email.
All you need to do is send us your requirements (material type, desired analysis, any applicable standard, urgency, number of samples, etc.). We will then send you a tailored technical and pricing proposal within 24-48 hours.
Analysis turnaround times at FILAB laboratory vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times tailored to your constraints and industrial urgencies.
An analytical laboratory can look for different types of contaminants: solvent residues, organic impurities, metal traces, degradation products, cleaning residues, particles, or substances originating from equipment and packaging materials.
Identifying an unknown contaminant relies on an analytical strategy adapted to its presumed nature. Depending on the sample, several techniques can be combined, such as chromatography, mass spectrometry, infrared spectroscopy, elemental analysis, or microscopy.
The technique depends on the contaminant being sought and the matrix. analysis may notably rely on GC-MS, HPLC, LC-MS/MS, LC-QTOF/MS, LC-Orbitrap, ICP-MS, ICP-OES, FTIR, or MEB-EDX.
Yes. ICP-MS and ICP-OES make it possible, in particular, to look for and quantify many metallic elements in different pharmaceutical matrices. These analysis can contribute to the assessment of elemental impurities.
Analysis of cleaning residues requires defining a method suited to the substance being sought and the support analyzed. The strategy may notably include an extraction step followed by chromatographic or elemental analysis, depending on the nature of the residue.
Yes, as part of an expert assessment approach. Comparing different samples — compliant product, contaminated product, raw material, equipment, or deposit — can help identify a common source and guide the investigation.
A contaminant can have a chemical, elemental, or morphological signature at the same time. Combining several techniques therefore makes it possible to cross-check information and obtain a more precise characterization, especially when an unknown substance needs to be identified.
Yes. When no existing method makes it possible to achieve the analytical objectives, a method development or adaptation approach can be considered in order to meet the specific characteristics of the sample and the required level of sensitivity.
