Farmakopideki NDEA and NDMA Limit Değerleri Güncellemesi



NDEA and NDMA Limit Değerleri

21.7.2019

Merhabalar,

Avrupa Farmakopisinde Valsartan, Losartan, Olmesartan, Irbesartan and Candersartan analizlerindeki NDEA and NDMA limit değerleri revize edilmiştir.İlgili açıklamayı aşağıda inceleyebilirsiniz.Yine aşağıda yer alan dosyalardan bu analizi gerçekleştirebileceğiniz 2 LCMS, 1 GCMS metodunu inceleyebilirsiniz.

        
NDMA and NDEA in Sartan Drugs and Drug Products by GC-MS
  NDMA LCMS Kinetex F5 
   Sartan Method Parameters NMBA  Luna C8

İlginiz için teşekkür eder, çalışmalarınızda kolaylıklar dileriz.

Ph Eur made a fast revision for the Valsartan, Losartan, Olmesartan, Irbesartan and Candersartan by implementing suitable test methods for the impurities levels of NDEA and NDMA with the release of Ph Eur 10.0

https://www.edqm.eu/en/news/control-nitrosamine-impurities-sartans-revision-five-ph-eur-monographs

  • Revising the Test section and adding the following requirement

Nitrosamines. Carry out the test by a suitable method. The substance to be examined does not contain either NDMA or NDEA above the limits provided below or both impurities at whatever level:

API

NDEA

Limit in ppm in API

NDMA

Limit in ppm in API

Valsartan

0.082

0.300

Losartan

0.177

0.640

Olmesartan

0.663

2.400

Irbesartan

0.088

0.320

Candesartan

0.820

3.000

 

The Ph. Eur. Commission adopted the revised monographs for publication in the 10th edition of the Ph. Eur. (publication schedule: July 2019; implementation date: 1st January 2020). These revised texts were not published in Pharmeuropa for public enquiry as the changes made are in line with the European Commission Decision C(2019) 2698 final which is applicable in all EU Member states (and with EEA relevance).