Analysis of Nitrosamines


Analysis of Nitrosamines

Nitrosamines are complex impurities and difficult to detect, you can find them in low concentration in a wide variety of sources including API Manufacturing, excipients, solvents. So even, they can produce themself in any part of the pharmaceutical production process.

Our LC-MS/MS technology is equipped with ionization to atmospheric pressure (APCI), achieving a perfect ionization to get the best sensitivity for nitrosamines compounds.

Possible causes that generate the presence of impurities (Nitrosamines).

• In the production of frying pans containing in its structure a tetrazol ring is intrinsically has a potential risk of forming nitrosamines, if not monitored the use of solvents, reagents or other raw materials.
• Make use of sodium nitrite (NaNO2), or other nitrous agents. They are a potential risk.
• In the API synthesis process using unsupervised solvents, reagents and catalysts can lead to nitrosamines.
• Execute processes of different pharmaceuticals that may be contaminated and may cause cross-contamination by using the same line.
• By a process of degradation of starting materials, intermediates and drugs. Note that this can potentially occur during the formulation or storage of the finished product.
• Make use of recovered materials (e.g., solvents, reagents and catalysts).

Our technical experts have developed a serie of methods to detect up to twelve nitrosamines in pharmaeutical products which will help you to guarantee your product safety and comply with the established requirements by regulatory entities COFEPRIS, FDA, EMA.

Detection of nitrosamines in Pharmaceutics products

N-nitrosodimethylamine NDMA
N-nitrosodiethylamine NDEA
N-Nitroso-di-isopropylamine NDIPA
N-Nitroso-ethyl-isopropylamine NEIPA
N-nitrosodi-n-butylamine NDBA
N-Nitroso-N-methyl-4-aminobutyric-acid NMBA
N-nitrosodi-n-propylamine NDPA
N-nitrosomethylethylamine NMEA
N-nitrosomorpholine NMOR
N-nitrosopiperidine NPIP
N-nitrosopyrrolidine NPYR
N-nitrosodiphenylamine NDPhA

The method developed by PRONTIUS Laboratories may be applicable in any raw materials (API), finished products and excipient. In addition, it can be necessary an specific validation to each pharmaceutical and / or manufacturer product.

With our experience in confirmatory tests to detect polluting waste, the results that PRONTIUS Laboratory give you, they have every trust guarantees to help our clients to take the best desitions about limits which are established in the regularization which is applicable to each pharmaceutical product.

Challenges in implementing and validating the nitrosamine and azide method.

Application note to determining nitrosamines in pharmaceuticals.

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