--- type: "WebPage" title: "Nitrosamines: analysis laboratory for the pharmaceutical industry" description: "Why monitor the presence of nitrosamines in pharmaceutical products? Chemical reactions between amines, ammonium salts and nitrites, cross-contamination, the use of ingredients already contaminated, packaging, cleaning protocols... the potential sources of nitrosamines are numerous.Classified or suspected as carcinogenic to humans,..." resource: "https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-pharmaceutical-nitrosamines/" tags: ["EN", "pll_61274e6914e43", "Anaïs DECAUX"] timestamp: "2026-08-18T09:01:44Z" published: "2021-08-26T08:18:48Z" language: "en" author: "bwa" --- # Nitrosamines: analysis laboratory for the pharmaceutical industry ## Why monitor the presence of nitrosamines in pharmaceutical products? Chemical reactions between amines, ammonium salts and nitrites, cross-contamination, the use of ingredients already contaminated, packaging, cleaning protocols... the potential sources of nitrosamines are numerous. [Classified or suspected as carcinogenic to humans](https://fr.wikipedia.org/wiki/Nitrosamine), European and American markets have repeatedly faced batch recalls of medicines for human use showing traces of nitrosamines. In 2018, the EMA then launched an investigation and awareness-raising process, supported by the competent authorities, to reduce the risk of nitrosamines being present in pharmaceutical products. In September 2019, the EMA and the CMD published a document entitled "*Informations on nitrosamines for marketing autorisation holders*" highlighting the importance of assessing the risk of nitrosamine contamination during manufacturing processes. New requirements were also introduced regarding the responsibilities of MA holders in controlling these impurities, both for active substances and for other components *(colorants, solvents, catalysts...)*. ## Our nitrosamine analysis FILAB laboratory has developed precise and optimized analytical methods to detect and quantify, among others, the following nitrosamines using the technique [LC-MSMS](https://filab.fr/en/our-technical-resources/laboratory-analysis-uplc/laboratory-analysis-hplc-lcms.md) :  - [NDMA (CAS: 62-75-9)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-ndma.md) - [NDEA (CAS: 55-18-5)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-ndea.md) - [NEIPA (CAS: 16339-04-1)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-neipa.md) - [NDIPA (CAS: 601-77-4)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-ndipa.md) - [NMBA (CAS: 61445-55-4)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-nmba.md) - [NDBA (CAS: 924-16-3)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-ndba.md) - [NMPA (CAS: 614-00-6)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-nmpa.md) - [NDPA (CAS: 621-64-7)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-of-ndpa-2.md) - NMEA (10595-95-6) - NMOR (59-89-2) - NPYR (930-55-2) - NPIP (621-64-7) - NMPEA (13256-11-6) - [NDELA (1116-54-7)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/analysis-of-ndela-according-to-iso-10130.md) - NDPh/NDPhA (86-30-6) - MeNP (16339-07-4) - NMPH (55557-03-4) - NEPhA (612-64-6) - NDINA (1207995-62-7) Detection limits for nitrosamine quantification range between **1 and 10 µk/kg** depending on the matrix and nitrosamine.  NDSRI - (nitrosamine impurities derived from the active substance) ## Targeted analysis of complex nitrosamines: Non-exhaustive list: 1-Nitroso-4-(2hydroxyethil)-piperazine, 2-Nitroso-octahydrocyclopenta[c]pyrrole, 4-Nitroso-Hydrochloroothiazide, N-Nitroso-Paroxetine, N-Nitroso-Zolmitriptan, N-Nitroso Biotin, N-Nitroso-Folic Acid, N-Nitroso-Clonidine, N-Nitroso-Diclofenac, N-Nitroso-Paroxetine, N-Nitroso-Salbutamol, Posaconazole Nitroso-Impurity 1, Posaconazole Nitroso-Impurity 2 [Learn more](https://filab.fr/nos-prestations/analyse/laboratoire-dosage-nitrosamine/analysis-ndsri/) ## FILAB supports pharmaceutical manufacturers in the research and quantification of nitrosamines ### Nitrosamines: what steps should be followed? In this regard, rapid measures must be taken to carry out a [nitrosamine analysis](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines.md), according to the following steps: Risk assessment according to ICH Q9 guidelines  ## Prioritization of [APIs](https://filab.fr/en/sectors-of-activity/health-pharmaceutical-cosmetics/laboratory-analysis-active-ingredients.md) and [medicines](https://filab.fr/en/sectors-of-activity/health-pharmaceutical-cosmetics/laboratory-analysis-medication.md) *(daily dose, treatment duration, route of administration, patient profile...)*. Determination of potential contamination risks by [nitrosamines](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines.md) based on production processes Detailed conclusions on the presence or absence of risks In its publication, the EMA requested a report on this assessment by a deadline set for **March 26, 2020**. SWISSMEDIC set this deadline for **May 15, 2020**. Confirmatory tests ## If a risk has been identified, analytical studies must be carried out according to the priority order defined in step 1, and in line with the following requirements: The analysis methods must **be validated** The LOQ must be **less than 30 ppb** The analysis must be carried out by a structure **compliant with GMP** The authorities must be informed if the results reveal the presence of nitrosamines, regardless of the level. Implementation of corrective actions ## Corrective actions (change in manufacturing process, modification of supplier specifications, etc.) must be implemented before September 26, 2022, i.e. 3 years after the publication of the EMA document, and by November 15, 2021 for SWISSMEDIC, i.e. 2 years after publication. ### Our services for nitrosamine analysis and quantification Quantification of nitrosamines in pharmaceutical products [Elemental Impurity Analysis (ICH Q3D context)](https://filab.fr/nos-prestations/analyse/laboratoire-analysis-ich-q3d/) Nitrosamine Analysis by[ATNC](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/nitrosamines-testing-atnc-method.md) Nitrosamine Analysis by [GC-TEA](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/analysis-nitrosamines-gc-tea.md) [Analytical Method Validation According to ICH Q2(R2)](https://filab.fr/en/our-services/our-expertise-services/laboratory-analytical-method-validation/validation-of-laboratory-analysis-methods-according-to-the-ich-q2-standard.md) [Method development](https://filab.fr/en/our-services/our-expertise-services/analytical-development.md) for nitrosamines : validation and transfer of nitrosamine quantification methods [Nitrosamine Testing in Cosmetic Products](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/analysis-nitrosamines-cosmetics.md) [Nitrosamine Impurity Analysis](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/analysis-nitrosamines-impurities-laboratory.md) [Nitrite and Nitrate Analysis](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-determination-nitrites-nitrates.md) ### Contact us for nitrosamine analysis in your pharmaceutical products If you need a [pharmaceutical analysis laboratory](https://filab.fr/en/sectors-of-activity/analysis-industry-pharmaceuticals.md) for nitrosamine testing in your pharmaceutical products, we can help! Ensure the compliance and safety of your products with our expert testing services. Contact us today to discuss your analytical needs and receive a tailored testing solution. [Contact us](http://contact@filab.fr) Discover our case study ## Nitrosamines in infusion bags: what does the FDA say and how can you protect against them? [Learn more](https://filab.fr/en/blog/2025/12/nitrosamines-in-infusion-bags-what-does-the-fda-say-and-how-can-you-protect-yourself.md)