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Nitrosamine
Asahi Kasei offers pharmaceutical excipient Ceolus™ with nitrite concentration of 0.1 ppm or less
PRESS RELEASE
February 27, 2024, Asahi Kasei Corp.
Contributing to lower risk of potentially carcinogenic nitrosamine impurities in pharmaceuticals
To contribute to reducing the risk of potentially carcinogenic nitrosamine impurities in pharmaceuticals and nutritional supplements, Asahi Kasei…
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Swissmedic updated its requirements for dealing with potential nitrosamine impurities in medicinal…
In summer 2018, drug regulatory authorities first became aware of nitrosamine impurities in a number of medicinal products, including antihypertensives in the sartans class. Trace amounts of nitrosamine impurities were also subsequently detected in other medicinal products. Swissmedic evaluates and…
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Revisiting the Landscape of Potential Small and Drug Substance Related Nitrosamines in…
N-Nitrosamines are a class of indirect acting mutagens, as their metabolic degradation leads to the formation of the DNA-alkylating diazonium ion. Following up on the in-silico identification of thousands of nitrosamines that can potentially be derived from small molecule drugs and their known…
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Nitrosamine acceptable intakes should consider variation in molecular weight: The implication of…
N-nitrosamines (NAs) are a class of compounds of which many, especially of the small dialkyl type, are indirect acting DNA alkylating mutagens. Their presence in pharmaceuticals is subject to very strict acceptable daily intake (AI) limits, which are traditionally expressed on a mass basis. Here we…
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Mitigating Nitrosamine Risks in Drug Products: Fuji Chemical Offers a Low-Risk Solution with…
See the latest issue of Fuji Chemical Industries Technical Newsletter: It presents Fujicalin®, a low-risk solution for mitigating nitrosamine risks in drug products.
Mitigating Nitrosamine Risks in Drug Products: Fuji Chemical Offers a Low-Risk Solution with Fujicalin®
Nitrosamine impurities…
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Nitrosamine Impurities and NDSRIs
A. FDA Issues notice on “Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities (NDSRIs) and requests comments”.
While the FDA’s investigation of the presence of nitrosamine impurities in drug products dates back to June 2018, it was not until more recently that…
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The Nitrosamine “Saga”: Lessons Learned from Five Years of Scrutiny
Abstract
The onset of the N-nitrosamine (NA) saga in 2018 was chiefly related to certain small dialkyl N-nitrosamines originating from the synthesis of the active pharmaceutical ingredient (API). However, the subsequent comprehensive assessments performed on APIs, formulated drug products, and…
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Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective…
Abstract
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…
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Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
Abstract
Risk control for nitrosamine impurities in drug products is currently a major challenge in the industry. Nitrosamines can form during drug product manufacturing and storage through the reaction of nitrites with amine-containing APIs or impurities. The level of nitrites in excipients and…
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AVICEL® PH LN – A Low Nitrite Microcrystalline Cellulose
Pharma Solutions at IFF provides you access to one of the broadest microcrystalline cellulose (MCC) portfolios in the industry. Backed by decades of innovation, and expertise, Avicel® PH offers a long history of manufacturing the highest-quality pharmaceutical grade MCC.
Our deep polymer…
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