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Risk of Impurities in Treatment of Schizophrenia

By Chon, Seung-Hyun | translator Choi HeeYoung

22.05.04 06:20:03

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Ministry of Food and Drug Safety ordered to submit Quetiapine impurity inspection data

Risk of Impurities in New Type Nitrosamines

Expanded to 9 impurity-risk medicines


The health authorities have started to check for impurities on Quetiapine-based drugs used as schizophrenia treatments. It is a new type of nitrosamines impurity that has not appeared before. The number of drugs that have raised the risk of impurities in Korea has increased to 10.

According to the industry on the 3rd, the MFDS recently ordered pharmaceutical companies to submit data for reviewing impurities N-Nitroso-Aryl Piperazine of Quetiapine-containing drugs. This is a proactive measure based on safety information that NNAP has been detected in Quetiapine recently. The MFDS ordered pharmaceutical companies to submit test results for representative manufacturing numbers among commercially available

Chon, Seung-Hyun(1000@dailypharm.com)
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