Genotoxic impurities (GTIs) and nitrosamines are substances that can pose a risk to human health due to their potential to cause DNA damage and increase the risk of cancer. The services on Genotoxic impurities and Nitrosamine assessment in pharmaceuticals and other products have become a significant focus for regulatory authorities and the industry in recent … Read more
The FDA’s recent announcement, on July 25th, 2023, of the “M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Guidance for Industry” is a significant development in pharmaceutical regulation. Understanding FDA Guidance The FDA’s guidance serves a crucial purpose: to provide a practical framework applicable to the categorization, … Read more
In the pharmaceutical industry’s dynamic landscape, one event consistently captures global attention: CPHI. As the 2023 edition is set to be hosted in Barcelona, we delve deeper to uncover what attendees and enthusiasts can expect. Where is CPHI Barcelona 2023? CPHI Barcelona 2023 is to be held in the vibrant city of Barcelona, Spain. Known … Read more
V dnešním farmaceutickém průmyslu se zaměření na identifikaci a hodnocení nitrosaminů v léčivých produktech a aktivních farmaceutických složkách (API) zintenzivnilo kvůli potenciální karcinogenní povaze těchto nečistot. Nitrosaminy vzbuzují velké obavy, protože mohou být genotoxické, mutagenní a možná i karcinogenní. Detekce nitrosaminových nečistot v běžně předepisovaných lécích pro různé způsoby léčby vyvolává poplach ohledně potenciálních zdrojů … Read more
Dans l’industrie pharmaceutique d’aujourd’hui, l’accent mis sur l’identification et l’évaluation des nitrosamines dans les produits pharmaceutiques et les ingrédients pharmaceutiques actifs (API) s’est intensifié en raison de la nature potentiellement cancérigène de ces impuretés. Les nitrosamines sont très préoccupantes car elles peuvent être génotoxiques, mutagènes et éventuellement cancérigènes. La détection des impuretés de nitrosamine dans … Read more
In Pharmaceutical Industry today’s main concern is the identification and presence of nitrosamines in drug products and drug substances. The manufacturers of active pharmaceutical ingredients (APIs) and drug products have the findings of nitrosamine impurities which may be likely human carcinogens and require the need for risk assessment strategy for potential nitrosamines and their presence. … Read more
In today’s dynamic healthcare landscape, powered by international trade and globalization, the critical role of maintaining and advancing quality standards for medicines cannot be overlooked. These standards are called Pharmacopeial Standards, and they form the bedrock of effective medical treatments, disease prevention, and the protection of public health. As medicines comprise diverse ingredients sourced from … Read more
Na indústria farmacêutica de hoje, o foco na identificação e avaliação de nitrosaminas em medicamentos e ingredientes farmacêuticos ativos (APIs) se intensificou devido à natureza potencialmente carcinogênica dessas impurezas. As nitrosaminas são motivo de grande preocupação, pois podem ser genotóxicas, mutagênicas e possivelmente cancerígenas. A detecção de impurezas de nitrosamina em medicamentos comumente prescritos usados … Read more
Na indústria farmacêutica, os fabricantes de APIs e produtos farmacêuticos têm achados de impurezas de nitrosamina que podem ser prováveis porque os carcinógenos humanos nas drogas eram uma grande preocupação. As agências reguladoras estudaram os detalhes sobre a presença de nitrosamina em alguns dos IFAs e medicamentos. Alguns dos medicamentos, incluindo bloqueadores dos receptores da … Read more
En la industria farmacéutica actual, el enfoque en la identificación y evaluación de nitrosaminas en productos farmacéuticos e ingredientes farmacéuticos activos (API) se ha intensificado debido a la naturaleza cancerígena potencial de estas impurezas. Las nitrosaminas son motivo de gran preocupación, ya que pueden ser genotóxicas, mutagénicas y posiblemente cancerígenas. La detección de impurezas de … Read more
The pharmaceutical industry is committed to producing safe and effective medicines. One aspect that has come under scrutiny is the presence of nitrosamine impurities in APIs and drug products. These impurities, considered potential human carcinogens, have led regulatory agencies to take a closer look. Let’s delve into the imperative task of Control of Nitrosamine Impurities … Read more
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