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The US Food and Drug Administration published guidance about the control of nitrosamine impurities in medicines. [32] [33] Health Canada published guidance about nitrosamine impurities in medications [34] and a list of established acceptable intake limits of nitrosamine impurities in medications. [35]
The FDA announcement followed a recall of three versions of metformin in Singapore, and the European Medicines Agency's request that manufacturers test for NDMA. [ 24 ] [ 25 ] In September 2019, N -nitrosodimethylamine was discovered in ranitidine products from a number of manufacturers, resulting in recalls.
Since then, FDA has determined that other types of nitrosamine compounds, e.g., N-Nitrosodiethylamine (NDEA), are present at unacceptable levels in APIs from multiple API producers of valsartan and other drugs in the ARB class." [72] In 2018, the FDA issued guidance to the industry on how to assess and control the impurities. [73]
In August 2020, the European Medicines Agency (EMA) provided guidance to marketing authorization holders on how to avoid the presence of nitrosamine impurities in human medicines and asked them to review all chemical and biological human medicines for the possible presence of nitrosamines and to test the products at risk. [62]
In cigarette smoke, NNN has been found in levels between 2.2 and 6.6 parts per million (ppm). The FDA has put limits of nitrosamines in other consumable products (such as cured meats) at levels below 10 parts per billion (ppb). [14]
On Monday, the U.S. Food and Drug Administration (FDA) announced that, for the first time, it is setting guidelines for an acceptable level of lead in processed baby food, including canned fruit ...
In 2018, the US Food and Drug Administration (FDA) reported that some versions of the angiotensin II receptor blocker medicines (including valsartan, losartan, irbesartan and other "-sartan" drugs) contain nitrosamine impurities. [19] Health Canada also reported nitrosamine impurities. [20]
In August 2020, the U.S. Food and Drug Administration (FDA) became aware of nitrosamine impurities in certain samples of rifapentine. [11] The FDA and manufacturers are investigating the origin of these impurities in rifapentine, and the agency is developing testing methods for regulators and industry to detect the 1-cyclopentyl-4 ...