Pharmaceutical samples containing NDMA, NDEA, or NDEA

Confirmatory Testing & Analytical Challenges
1

Hey all,

I have a question. For my research I am developing a method for the determination of NDMA, NDEA, or NDEA in pharmaceutical samples. First I am validating this method according to the ICH guidelines. After completion of the validation, I want to test the method on a real drug sample. For this reason I am searching for a pharmaceutical product (or API) which is known or suspected to contain the mentioned nitrosamines.

Does anybody know a product which is still possible to buy and could potentially contain one of the mentioned nitrosamines?

Thanks in advance!!

2

Hi Tom,

You can choose Metformin for your study. It has issue of NDMA impurity and so many companies recalled their drug substance and drug products due to its presence in their products .

For both the impurities you can choose any sartan products such as Irbesartan, Candesartan, Olmesartan, Losartan or Valsartan and conduct your study.

Thanks and Regards,
Mittal B.

3

Hey Mittalkumar,

Thanks for the help! I’ll choose one of tbose you mentioned.

Kind regards,

Tom