Nitrites as precursors of N-nitrosation in pharmaceutical samples – A trace level analysis

Jireš, Jakub; Douša, Michal

doi:10.1016/j.jpba.2022.114677

Cited by 8 publications

(8 citation statements)

References 15 publications

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“…For instance, in terms of analytical developments, tools to detect very low levels (ppb) of nitrite have become available. 33 A nitrite excipient database 34 has been created by an organization called Lhasa using input from a consortium of pharmaceutical companies, and its population and utilization 35 is steadily increasing (92 excipients covered in the most recent version to date, 2023.1.0). Cooperation between some drug product manufacturers, marketing authorization holders and excipient suppliers has allowed for a better understanding of the nitrite content of various excipients.…”

Section: Vulnerable Amines In Excipientsmentioning

confidence: 99%

“…In the past couple of years further research has been conducted in this area. For instance, in terms of analytical developments, tools to detect very low levels (ppb) of nitrite have become available . A nitrite excipient database has been created by an organization called Lhasa using input from a consortium of pharmaceutical companies, and its population and utilization is steadily increasing (92 excipients covered in the most recent version to date, 2023.1.0).…”

Section: Excipients As Risk Factors In the Generation Of Ndsrismentioning

confidence: 99%

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Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies

Cioc

Joyce

Mayr

et al. 2023

Org. Process Res. Dev.

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The detection of N-nitrosamine impurities in medicines and the recent emergence of nitrosamine drug substance related impurities (NDSRIs) has posed a great challenge to manufacturers of drug products and regulators alike. NDSRIs are primarily associated with reactions occurring in the drug product which brings particular complexity. This paper will explore the current technical knowledge surrounding the formation of these impurities, including the risk factors, reaction conditions, and potential mitigation strategies. Scientific understanding of these areas is still evolving, and we will highlight both the scientific progress made and discuss the significant gaps in mechanistic knowledge still remaining. These gaps render accurate predictions of NDSRI formation extremely challenging. The pharmaceutical industry should continue to work on potential mitigation strategies and generation of additional scientific data to address the mechanistic gaps. Regulatory guidance and policy will continue to advance and adapt in response to further changes in scientific understanding.

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Section: Vulnerable Amines In Excipientsmentioning

confidence: 99%

Section: Excipients As Risk Factors In the Generation Of Ndsrismentioning

confidence: 99%

Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies

Cioc

Joyce

Mayr

et al. 2023

Org. Process Res. Dev.

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“…Consequently, monitoring the nitrite content in the environment, public health and the food industry is crucial, and the development of simple, sensitive and efficient analytical tools is essential and must be addressed. Until now, different types of spectroscopic [17,18], chromatographic [19][20][21], capillary electrophoretic [22] and electrochemical methods [23][24][25] have been developed and used for nitrite detection. Among these, due to its rapidity, sensibility and low costs, the electrochemical aproach has become one of the most popular and extensively used analytical tools [26].…”

Section: Introductionmentioning

confidence: 99%

Highly Sensitive Graphene-Based Electrochemical Sensor for Nitrite Assay in Waters

et al. 2023

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The importance of nitrite ions has long been recognized due to their extensive use in environmental chemistry and public health. The growing use of nitrogen fertilizers and additives containing nitrite in processed food items has increased exposure and, as a result, generated concerns about potential harmful health consequences. This work presents the development of an electrochemical sensor based on graphene/glassy carbon electrode (EGr/GC) with applicability in trace level detection of nitrite in water samples. According to the structural characterization of the exfoliated material, it appears as a mixture of graphene oxide (GO; 21.53%), few-layers graphene (FLG; 73.25%) and multi-layers graphene (MLG; 5.22%) and exhibits remarkable enhanced sensing response towards nitrite compared to the bare electrode (three orders of magnitude higher). The EGr/GC sensor demonstrated a linear range between 3 × 10−7 and 10−3 M for square wave voltammetry (SWV) and between 3 × 10−7 and 4 × 10−4 M for amperometry (AMP), with a low limit of detection LOD (9.9 × 10−8 M). Excellent operational stability, repeatability and interference-capability were displayed by the modified electrode. Furthermore, the practical applicability of the sensor was tested in commercially available waters with excellent results.

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Section: Introductionmentioning

confidence: 99%

“…In the cosmetics industry, nitrosamines were reported in hair dyes, nail polish, and other personal care products. Nitrosamines have also been reported in pharmaceuticals, particularly in products that contain nitrosatable compounds 2 7 8 9 . Recent reports have shown that nitrosamine impurities have been found in several drugs, including the anti-hypertensive drug valsartan and metformin an anti-diabetic drug widely used by the public 10 11 12 .…”

Section: Introductionmentioning

confidence: 99%

Nitrosamine Impurities in Herbal Formulations: A Review of Risks and Mitigation Strategies

et al. 2023

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Nitrosamines are a class of chemical compounds that have been found to be impurities in a variety of pharmaceutical products. These impurities have raised concerns due to their potential carcinogenic effects. Recent studies have identified nitrosamines as impurities in a number of pharmaceutical products including angiotensin II receptor blockers (ARBs) and proton pump inhibitors (PPIs). The presence of nitrosamines in these products has led to recalls and market withdrawals. In addition to pharmaceuticals, nitrosamines have also been found in some herbal medicines particularly those containing traditional Chinese medicinal ingredients. The presence of nitrosamines in herbal formulations poses a significant risk to public health and highlights the need for quality control and regulations in the herbal drug industry. The present review article aims to discuss nitrosamine impurities (NMI) prominent causes, risks and scientific strategies for preventing NMI in herbal formulations. The primary objective of this study is to examine the origins of nitrosamine contamination in herbal formulations, the risks associated with these contaminants, and the methods for reducing them. The significance of thorough testing and examination before releasing herbal products to the public is also emphasized. In conclusion, the presence of nitrosamines is not limited to pharmaceutical products and poses a significant threat to the safety of herbal drugs as well. Adequate testing and extensive research are crucial for producing and distributing herbal medicines to the general population.

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Nitrites as precursors of N-nitrosation in pharmaceutical samples – A trace level analysis

Cited by 8 publications

References 15 publications

Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies

Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies

Highly Sensitive Graphene-Based Electrochemical Sensor for Nitrite Assay in Waters

Nitrosamine Impurities in Herbal Formulations: A Review of Risks and Mitigation Strategies

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