Laboratory analysis of NMOR

You wish to analyze and determine the NMOR (CAS: 59-89-2) in your product?

NMOR, a chemical compound classified as a hazardous substance

Nitrosomorpholine 59-89-2 (NMOR) is a molecule belonging to the nitrosamine family.

Moreover, NMOR, like all nitrosamines, has been classified as a hazardous and potentially carcinogenic substance for humans by the IARC and the WHO.

In addition, nitrosamines are also monitored by the ANSM (Agence nationale de sécurité du médicament et des produits de santé) which conducts further studies on the risks associated with the presence of nitrosamines in drugs.

FILAB, laboratory for the analysis and determination of NMOR in industrial products

The laboratory provides state-of-the-art analytical equipment for the determination of NMOR and its precursors in trace amounts in all types of matrices (food, pharmaceutical, cosmetic, polymer, water, etc.). FILAB assists manufacturers in the development and quality control of their products, following the regulatory changes. 

Analyses are carried out using, among others, the LC-MSMS technique.

FILAB also offers specific method development or method validation (ICH Q2) on your matrices. 

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Nitrosamines, including Nitrosomorpholine (NMOR), are carcinogenic compounds that can be formed during the manufacturing process of certain products, such as rubber products, pesticides, and cosmetics.

 

It is crucial to analyze and determine the presence of NMOR in your product to ensure that it complies with safety regulations and standards. Exposure to high levels of NMOR can be harmful to human health and may increase the risk of cancer.

 

Regular monitoring and testing for NMOR can help identify potential sources of contamination and allow for corrective action to be taken. This can help protect both consumers and your business from potential harm and legal action.

Nitrosamines are often found in pharmaceuticals as they can form during the manufacturing process of certain drugs that contain secondary or tertiary amines, including ranitidine and metformin. They can also be formed as impurities in the drug when it is exposed to nitrite or nitrous acid.

There are several methods that can be used to analyze and dose Nitrosomorpholine (NMOR) in pharmaceuticals. Two common methods are:

 

  • High-Performance Liquid Chromatography (HPLC): This method involves separating the components of a mixture using a liquid mobile phase that is passed through a column containing a stationary phase. The separated components are then detected using ultraviolet (UV) or mass spectrometry (MS) methods.

 

  • Gas Chromatography-Mass Spectrometry (GC-MS): This method involves separating the components of a mixture using a gas mobile phase that is passed through a column containing a stationary phase. The separated components are then detected using mass spectrometry (MS).

 

In terms of dosing, the amount of NMOR in pharmaceuticals can be determined by measuring the concentration of the compound in a sample. This is typically done using a calibration curve, which relates the measured concentration to a known standard concentration.

 

It is important to note that dosing for NMOR in pharmaceuticals should always be done in compliance with safety regulations and guidelines. The use of NMOR in pharmaceuticals should also be minimized whenever possible to reduce potential health risks.

 

NMOR can be commonly found in the rubber industry due to its use as a vulcanization accelerator. Vulcanization is a process used to strengthen and harden rubber by undergoing a chemical reaction with sulfur or other curatives in the presence of an accelerator, such as NMOR.

 

During the vulcanization process, NMOR can react with other compounds to form nitrosamines, including N-nitrosomorpholine (NNM), which is a known carcinogen. Therefore, NMOR is considered a potential impurity in rubber products and it is important to regularly test for its presence and minimize its usage in manufacturing processes.

 

In addition to the rubber industry, NMOR can be found in other industries that use it as an intermediate in the production of certain chemicals (pesticides, dyes) or as an additive in other products (cosmetics, water treatment). However, the use of NMOR is generally declining due to its potential health risks and regulatory measures to limit its use and exposure.

Anaïs DECAUX
Anaïs DECAUX Customer Support Manager
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