Nitrosamine contamination testing

Nitrosamine contamination testing is performed by HPLC MS-MS on finished products and active ingredients. After analytical method development, the analytical method is validated according to the current guidelines and customer requirements. We are able to quantify nitrosamine contaminants at ppb levels in finished products and raw materials. This allows us to reliably measure the detection limit of the analytical method established as a function of the limit of contamination (usually the detection limit is one tenth of the limit value).

Analysis of contaminants listed in the pharmacopoeia (Ph. Eur. 2.5.42):

For a very large number of finished products (containing one, two or three active ingredients), mostly quantitative analytical methods have been developed and validated for the following two impurities.

• N-Nitrosodimethylamine NDMA CAS No.: 62-75-9
• N-Nitrosodiethylamine NDEA CAS No.: 55-18-5

In the analytical methods, N-nitrosodimethylamine-D6 and N-nitrosodiethylamine-D10 are used as internal standards, which increases the robustness of the method.

In the case of new inquiries and new formulations, the following development phases are followed for the above contaminants:

• Verification of the specificity of our existing method for the new formulation;
• Following a test measurement, we help decide on the type of validation of the analytical method:
  • If the measured contaminant is below the detection limit (one tenth of the limit value), we propose LIMIT test validation
  • If the measured contaminant is above the limit of detection (one tenth of the limit value), we recommend a QUANTITATIVE test validation
• Analytical method validation and preparation of documentation (in English)

 Active ingredient specific contaminants:

• We have analytical methods for the following active ingredient specific nitrosamine contaminants:

The list above is constantly growing.

Contact:

Dr. Tolokán Antal
+3618723634
tolokan.antal@laboratorium.hu

Examination Order Form (F20)