Highly sensitive LC – MS/MS method for the determination of NDMA, NDEA, NDIPA, NMBA, NEIPA and NDBA in Metformin drug substance

//Highly sensitive LC – MS/MS method for the determination of NDMA, NDEA, NDIPA, NMBA, NEIPA and NDBA in Metformin drug substance

Highly sensitive LC – MS/MS method for the determination of NDMA, NDEA, NDIPA, NMBA, NEIPA and NDBA in Metformin drug substance

 

Health Sciences Authority (HSA) of Singapore on 4th December 2019[1] recalled three out of 46
locally marketed Metformin medicines after presence of NDMA “above the
internationally acceptable level” and this came into . Subsequently, both the
US Food and Drug  (FDA) and the European Medicines Agency (EMA) have
released regular updated into their into the causes of medicine contamination.
Metformin (Figure 1) is the -line drug control of high blood sugar levels in patients with type 2
diabetes, particularly people who are overweight.
Here, a single LC-MS/MS method is developed for the quantitation of six nitrosamines namely
NDMA, NDEA, NDIPA, NMBA, NEIPA and NDBA (Figure 2) in Metformin drug

 

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By | 2021-02-15T10:49:36+00:00 February 15th, 2021|Categories: Uncategorized|0 Comments

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