Service for identification of unknown impurities by LC-MS/MS in pharmaceutical products
High-quality analysis of unknown impurities in pharmaceutical products is a key element in ensuring patient safety and compliance with international regulations (such as ICH guidelines). Our specialized service based on LC-MS/MS (liquid chromatography coupled mass spectrometry) technique enables precise identification of the chemical structure of impurities present in samples of raw materials, active substances and finished drug products.
Why is it essential to identify contaminants?
Detection and identification of unknown contaminants provide the basis for:
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Toxicological risk assessment and regulatory compliance assurance (e.g., EMA ICH Q3A/B),
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determine the potential source of contamination – from degradation of the active ingredient (API) or formulation components to transfer from the package,
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improving production processes and eliminating the causes of pollution,
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Preparation of full registration dossiers or responses to inquiries from regulatory authorities (e.g. URPL, EMA, FDA),
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Protecting patients’ health by reducing exposure to potentially harmful compounds.
Our approach to identifying contamination
Identification of contaminants is a complex analytical process that aims to determine the elemental composition, chemical structure and potential source of an unknown compound. In our laboratory, we perform it based on advanced technologies and standardized procedures:
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Reproducing the customer’s analytical method – based on the customer’s documentation, we reproduce the existing method for determining impurities (HPLC-UV/Vis).
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Adapting LC conditions to mass spectrometry – we optimize HPLC parameters to be compatible with MS analysis, while maintaining the required selectivity and resolution.
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Registration of mass and fragmentation spectra – we use a high-resolution ZenoTOF 7600 mass spectrometer (Sciex) to obtain precise MS and MS/MS (CID and EAD) spectra.
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Data analysis and interpretation of results – we determine the sum formula and chemical structure of the compound and the potential source of its presence in the sample.
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Final report – we provide a full report including a description of the methodology, results and interpretation.
What do you gain by using our service?
Using our service, you receive precise and confirmed data on the chemical structure of the identified contaminant. This reduces the time required to respond to regulatory authorities. Our analyses also support the resolution of technological and quality problems occurring in the production process. As a result, they contribute to increased safety and improved quality of the final pharmaceutical product.
Application of the LC-MS/MS method
The LC-MS/MS technique is now considered the gold standard for identifying unknown contaminants, thanks to its exceptional sensitivity, selectivity and ability to obtain structural information at the molecular level. Combined with the experience of our team, this allows for reliable analysis of even trace amounts of compounds..
📞 Contac us
If you would like to get a quote for the service, find out the turnaround time or consult the scope of the analysis with our experts, feel free to contact us. We offer a flexible approach, tailored to the specifics of the sample and the needs of your organization. For the sake of confidentiality and security of information, we offer the possibility of signing a Non-Disclosure Agreement (NDA) before the start of cooperation. This guarantees full protection of the data sent by the client, including technical documentation, sample information and analytical results.