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Nitrosamine Impurities in Herbal Formulations: A Review of Risks and Mitigation Strategies.
Shekhar, Nunavath Raja; Nagappan, Krishnaveni; Singh, Madhu Tanya; Dhanabal, S P.
Afiliación
  • Shekhar NR; Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India.
  • Nagappan K; Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India.
  • Singh MT; Department of Pharmacology, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India.
  • Dhanabal SP; Department of Pharmacognosy, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India.
Drug Res (Stuttg) ; 73(8): 431-440, 2023 Oct.
Article en En | MEDLINE | ID: mdl-37487523
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Plantas Medicinales / Nitrosaminas Tipo de estudio: Etiology_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Drug Res (Stuttg) Año: 2023 Tipo del documento: Article País de afiliación: India Pais de publicación: Alemania
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Plantas Medicinales / Nitrosaminas Tipo de estudio: Etiology_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Drug Res (Stuttg) Año: 2023 Tipo del documento: Article País de afiliación: India Pais de publicación: Alemania