Ministry of Food and Drug Safety of the Republic of Korea detected N-Nitroso-Atenolol in atenolol formulation products

It’s wierd how they talk about N-nitro-Atenolol but then they say the Nitrosamine is NMDA. If they actually refert to the NMDA impurity, it should be treated differently as if there was a risk of an NDRI’s (N-Nitroso-Atenolol)?

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Agree…Some confusion on the part the way it was reported

I translate a part of Korean news paper. hope to read

Recently, in the domestic Korean pharmaceutical industry, arose over the detection of nitrosamine impurities “N-nitroso atenolol”, known as carcinogenic substances, in atenolol preparations using Indian API materials.
On this day, the Ministry of Food and Drug Safety was cautious about the detection of impurities in atenolol preparations. This is because nitroso-atenolol is a nitrosamine impurity, but the level of risk has not yet been identified. Another reason why immediate action is delayed is that there are no specific cases regulated by regulatory authorities in overseas.


Yes agree it is NDMA , some confusion during write up

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The Korean regulatory agency does not withdraw atenolol drugs and allows them temporarily. In the case of impurities without enough toxicity data to decide acceptable standards, the agency will apply the criteria of 178 nanograms per day for 12 months, according to the article.

And director Kim said, “Regulatory agencies worldwide are also concerned about the detection of impurities from atenolol drugs, trying to grasp their harmfulness. We are also positively communicating with our foreign counterparts. It may cause only confusion if we withdraw them hastily without scientific grounds.”