New Era of Nitroso amine

History of Nitroso amines.

Two British scientists John Barnes and Peter Magee, reported that a simple member of the large class of N-nitrosamines, dimethylnitrosamine, produced liver tumours in rats. After that it shows90 % of nitroso amine have carcinogenic properties. So it gives more importance to these compounds in pharmaceutical industry and study of these compounds are necessary.

After of early September 2019, regulatory authorities announced that the market formulations ofranitidine have unacceptable limit of NDMA impurities. Then these compounds again came in highlight.

What is nitroso amine compounds?

Nitroso compounds are the compounds which contains R2N-NO bond. These bond can form secondary amine only and for synthesis nitroso compounds amine should have basic in nature. If the lone pair of nitrogen is involved in aromaticity then it does not form the nitroso compounds like pyrrole ring, pyrazole ring.

How nitroso amine compounds forms?

Nitrite makes most favourable condition for the formation nitroso compounds. Nitrite gets converted into nitrous acid(HNO2) and HNO2 gets dimerise into N2O3 with loss of water. N2O3 reacts with secondary amine to form nitroso compounds. Primary amine undergoes diazotization with N2O3 while tertiary amine does not reacts with the N2O3.

Origin of nitroso compounds

Nitroso compounds are mainly form from chemicals which are used in synthesis of api, Intermediate, API in favourable condition. Once they form they can carry in finished product.

Nitroso compounds and pharmaceutical industry.

Nitroso reference standards are used in the pharmaceutical industry for various purposes, primarily in the context of quality control, research and development, and regulatory compliance. Nitroso compounds, which contain the nitroso functional group (-NO), may be used inpharmaceuticals or may be impurities that need to be monitored and controlled. Here we discuss some brief use of nitroso compounds in pharmaceutical industry.

Analytical Method Development and Validation:

Nitroso reference standards are employed to develop and validate analytical methods, such as chromatographic techniques (HPLC, GC) or spectroscopic methods, for the accurate and precise quantification of nitroso-containing compounds in pharmaceutical products.

Quality Control (QC) Testing:

Nitroso reference standards serve as benchmark materials for quality control testing of pharmaceutical products. These standards help ensure that the manufacturing processes areconsistent, and the final products meet the required specifications and regulatory standards.

Identification and Purity Assessment:

These reference standard also used to indentify the nitroso compounds and also used to check the limit of nitroso compounds in finished product. This is helps to ensure the safety of product. In summary, nitroso reference standards are integral to ensuring the quality, safety, and efficacy of pharmaceutical products. They play a crucial role in various stages of drug development, production, and regulatory compliance within the pharmaceutical industry.

1. Analytical Method Development and Validation:

Nitroso reference standards are employed to develop and validate analytical methods, such as chromatographic techniques (HPLC, GC) or spectroscopic methods, for the accurate and precise quantification of nitroso-containing compounds in pharmaceutical products. Nitroso reference standards are used in the pharmaceutical industry for various purposes, primarily in the context of quality control, research and development, and regulatory compliance. Nitroso compounds, which contain the nitroso functional group (-NO), may be used in pharmaceuticals or may be impurities that need to be monitored and controlled. Here are some ways in which nitroso reference standards are utilized in the pharmaceutical industry:

2. Quality Control (QC) Testing:

Nitroso reference standards serve as benchmark materials for quality control testing of pharmaceutical products. These standards help ensure that the manufacturing processes are consistent, and the final products meet the required  specifications and regulatory standards.

3. Identification and Purity Assessment:

Pharmaceutical manufacturers use nitroso reference standards to verify the identity and assess the purity of nitroso compounds in drug substances and finished pharmaceutical products. This is crucial for maintaining product consistency and safety.

4. Research and Development:

In the research and development phase, nitroso reference standards are utilized to investigate the properties, behavior, and potential uses of nitroso compounds in drug development. Researchers may study the effects of these compounds on biological systems and assess their potential therapeutic applications.

5. Regulatory Compliance:

Regulatory agencies often require pharmaceutical companies to use reference standards as part of the submission and approval process. Nitroso reference standards play a role in demonstrating the quality, safety, and efficacy of pharmaceutical products in accordance with regulatory guidelines.

6. Stability Testing:

Nitroso reference standards are employed in stability testing to monitor the degradation of pharmaceutical products over time. This helps ensure that the products remain within acceptable quality limits throughout their shelf life.

7. Training and Education:

Reference standards are valuable tools for training and education within the pharmaceutical industry. They enable laboratory personnel to familiarize themselves with the characteristics of nitroso compounds and the methods used for their analysis. In summary, nitroso reference standards are integral to ensuring the quality, safety, and efficacy of pharmaceutical products. They play a crucial role in various stages of drug development, production, and regulatory compliance within the pharmaceutical industry.