Confidence in product safety and compliance
Impurities are a key concern within the pharmaceutical industry. Even trace amounts of metals, solvents or contaminants can affect product safety, regulatory compliance and market access. As a result, the requirements for impurity profiling continue to become more stringent.
Normec supports pharmaceutical manufacturers, importers, wholesalers and active pharmaceutical ingredient (API) manufacturers with advanced analysis of pharmaceutical impurities. From our GMP-certified laboratory, we help organisations identify contamination risks at an early stage and demonstrate ongoing compliance.
Analysis of elemental impurities, nitrosamines and residual solvents
Our services focus on identifying, quantifying and controlling a wide range of impurities in raw materials, excipients and finished products.
We support organisations with:
- Analysis of elemental impurities in accordance with ICH Q3D
- Analysis of residual solvents in accordance with ICH Q3C
- Risk assessment and analysis of nitrosamines
- Cleaning validation and verification
- Analysis of active pharmaceutical ingredients (APIs)
- Testing of raw materials and finished products
We work in accordance with international guidelines, including USP <232>/<233>, EP 2.4.20 / 5.20, as well as customer-specific validated methods.
Reliable results
Accurate impurity detection requires highly sensitive analytical techniques and validated methods. Normec uses advanced instrumentation to analyse both organic and inorganic materials.
Our analytical techniques include:
- ICP-MS for highly sensitive multi-element analysis
- Atomic Absorption Spectrometry (AAS)
- Atomic Emission Spectrometry (AES)
- Gas chromatography for residual solvent analysis
- Microwave digestion for sample preparation
These techniques enable us to detect elemental impurities and contaminants at concentrations ranging from parts per trillion (ppt) to higher parts per million (ppm) levels. This helps organisations identify risks earlier and maintain compliance in international markets.
Quality assurance and cleaning validation
Within pharmaceutical manufacturing, impurity profiling is not limited to laboratory analysis. It also involves controlling risks associated with manufacturing processes and equipment.
That is why we also support organisations with cleaning validation and verification. We assess whether cleaning procedures effectively remove product residues, contaminants and cleaning agents.
With our support, you can:
- Improve the control of contamination risks
- Demonstrate product safety
- Strengthen compliance with international guidelines
- Support more efficient product release
- Be well prepared for audits and inspections
Normec as your trusted partner
With our in-house QA teams, validated analytical methods and specialist expertise, we help organisations bring safe and reliable pharmaceutical products to market. Together, we support quality, regulatory compliance and patient safety across the life sciences sector.
Would you like to know more about pharmaceutical impurities and contaminants?
Frequently Asked Questions
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Impurity profiling is the analysis and control of impurities in pharmaceutical products, raw materials and active pharmaceutical ingredients.
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Elemental impurities are trace amounts of metals or other chemical elements that may be present in pharmaceutical products or manufacturing processes.
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Residual solvents can affect product safety and must comply with internationally accepted safety limits.
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Nitrosamines are chemical compounds that can form under certain conditions and are strictly regulated because of their potential health risks.
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Cleaning validation verifies that manufacturing equipment has been cleaned effectively and is free from product residues and contaminants.
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We work in accordance with international guidelines, including USP, EP and ICH standards such as ICH Q3D and ICH Q3C.
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We support pharmaceutical manufacturers, API manufacturers, importers, wholesalers and other organisations operating within the life sciences sector.