--- type: "WebPage" title: "Nitrites & Nitrates Analysis" description: "Nitrosamines are formed by the nitrosation between nitrites or nitrates and amines or amides. The final molecule is the result of the addition of a nitroso radical and the formed compound is only stable with secondary amines. Identification & Quantification..." resource: "https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-determination-nitrites-nitrates/" tags: ["EN", "pll_6171670f681c4", "Anaïs DECAUX"] timestamp: "2026-03-25T08:23:18Z" published: "2021-10-21T13:28:58Z" language: "en" author: "Laure Durieux" --- # Nitrites & Nitrates Analysis Nitrosamines are formed by the nitrosation between nitrites or nitrates and amines or amides. The final molecule is the result of the addition of a nitroso radical and the formed compound is only stable with secondary amines. ## Identification & Quantification of Nitrites and Nitrates ### Ensure product safety with accurate Nitrites & Nitrates Testing The presence of **nitrites and nitrates** in pharmaceutical manufacturing processes can lead to the unintended formation of **nitrosamines**, classified as potential carcinogens. Their formation occurs through **nitrosation reactions**, particularly when a precursor amine reacts with a nitrosating agent such as nitrite ions. Ensuring strict control of these substances is essential to meet regulatory requirements and guarantee patient safety. ## Our nitrosamine analysis services - [NDEA (CAS : 55-18-5)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-ndea.md) - [NDMA (CAS : 62-75-9)](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-ndma.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) - MeNP (16339-07-4) - 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) - NMPH (55557-03-4) - NEPhA (612-64-6) - NDINA (1207995-62-7) 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/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/ndsri-nitrosamine-impurities-derived-from-the-active-substance-analysis-laboratory/) ## Why analyze Nitrites and Nitrates? The[pharmaceutical industry](https://filab.fr/secteur-activite/analyse-industrie-pharmaceutique.md) must mitigate the risk of**Nitrosamine Drug Substance-Related Impurities (NDSRIs)** and other nitrosamine contaminants. This involves controlling both the nitrite sources and amine precursors that may lead to their formation. Our analytical services help you: - **Prevent nitrosamine formation** by detecting nitrosating agents in raw materials and intermediates - **Ensure compliance with regulatory guidelines** from agencies such as the FDA and EMA - **Optimize manufacturing processe**s by identifying potential sources of nitrosation - **Improve product stability** by assessing degradation risks related to nitrate and nitrite contamination.  **Prevent nitrosamine formation** by detecting nitrosating agents in raw materials and intermediates **Optimize manufacturing processe**s by identifying potential sources of nitrosation **Ensure compliance with regulatory guidelines** from agencies such as the FDA and EMA **Improve product stability** by assessing degradation risks related to nitrate and nitrite contamination.  ### Our Nitrites & Nitrates Testing Services We offer **comprehensive analytical solutions** for the detection and quantification of nitrites and nitrates in pharmaceutical raw materials, intermediates, and final products. Our services include: **Trace-level detection** using advanced analytical techniques such as **[IC (Ion Chromatography)](https://filab.fr/en/our-technical-resources/laboratory-ion-chromatography.md), [LC-MS/MS (Liquid Chromatography-Mass Spectrometry](https://filab.fr/en/our-technical-resources/altis-lc-msms-analysis.md)), and UV-Vis Spectrophotometry**. **Risk assessment** for cross-contamination from solvents, catalysts, or production equipment [Analytical method validation according to ICH Q2(R2)](https://filab.fr/en/our-services/our-expertise-services/life-cycle-of-an-analytical-method-in-the-laboratory/laboratory-analytical-method-validation/validation-of-laboratory-analysis-methods-according-to-the-ich-q2-standard/) **Quantification of nitrosating agents** in [active pharmaceutical ingredients](https://filab.fr/en/sectors-of-activity/health-pharmaceutical-cosmetics/laboratory-analysis-api.md) (APIs), excipients, and packaging materials **Custom testing solutions** tailored to your specific formulation and manufacturing conditions ## Contact us for Nitrites & Nitrates Testing If you need a **trusted laboratory** to analyze nitrites and nitrates in your pharmaceutical process, **we can help!** Ensure compliance and product safety with our expert testing services. 📩 [**Contact us today**](mailto:contact@filab.fr) to discuss your analytical needs and receive a tailored testing solution.