1,4-DIOXANE FACTS
Insight and compliance strategies for manufacturers facing the new EPA limits
The EPA has designated 1,4-dioxane as a suspected carcinogen. Consequently, New York regulations signed into law by Gov. Andrew Cuomo in December 2019 lower the acceptable amount of 1,4-dioxane allowed in household cleaning, cosmetics and personal care products over the next two years.
NITROSAMINES
FDA Issues Final Guidance For Control Of Nitrosamine Impurities In Human Drugs
On Wednesday, September 4, 2024, the FDA released its final guidance for industry titled “Control of Nitrosamine Impurities in Human Drugs.” This guidance updates the previous version issued on February 24, 2021. It outlines two main types of nitrosamine impurities: small-molecule nitrosamine impurities, which are structurally distinct from the active pharmaceutical ingredient (API), and nitrosamine drug substance-related impurities (NDSRIs), which are structurally similar to the API and are typically specific to each API. The guidance addresses potential sources of nitrosamine impurities, methods for detecting them, and offers recommendations for risk assessments, testing, and implementing controls to prevent or minimize their presence in APIs and drug products. It also includes suggestions for an alternative bioequivalence approach for manufacturers and applicants who choose to reformulate their products to address nitrosamine impurities.
