Nitrosamine Determination

Analytik von Nitrosaminen

Our services for the determination of nitrosamine

  • Accredited and extensively validated methods: Analyses using high-resolution mass spectrometry or GC-MS/MS under GLP and DIN ISO 17025 conditions
  • Validation of a GC-MS/MS method under GMP conditions
  • Many years of experience in nitrosamine analysis, even from complex matrices
  • Expertise in sample preparation (air sampling, extractions (solid phases or Soxhlet), steam distillation, etc.)
  • Development and validation of matrix-specific analytical methods

Methods for the analysis of nitrosamines

The substance group of nitrosamines must be minimized due to its carcinogenicity. If control measurements on drugs, plant protection products, materials or components lead to positive results, the formation of nitrosamines during the production process or the introduction of nitrosamines through raw materials is a possible source of contamination. However, a further significant contamination path is the downstream formation during use from secondary amines and nitrogen oxides from the ambient air.

High-performance analytics are of great importance in the clarification of contamination paths and the quantification of nitrosamines:

CURRENTA Analytics has access to methods at various quality levels. With the GC-MS/MS samples can be analyzed according to GMP regulations, within the scope of GLP studies or under DIN ISO 17025 conditions.

In addition, a method developed by CURRENTA Analytik using high-resolution mass spectrometry is available for services under DIN ISO 17025 conditions and for GLP studies. This technique offers high sensitivity and selectivity.

Risk assessment of nitrosamine contamination in medicinal products

In September 2019, the European Medicines Agency (EMA) required all marketing authorisation holders of chemically synthesised drugs to carry out a risk assessment for nitrosamine impurities.

If a risk is identified after the theoretical evaluation, the second step requires an analysis with validated and sensitive methods. The EMA requests that the results of the tests be finalised at the latest three years after publication of the notification.

Validated method under GMP conditions

CURRENTA Analytics is validating a specially developed GC-MS/MS method for the determination of ten different nitrosamines under GMP conditions. The experienced experts can fall back on various possibilities of sample preparation.

Samples such as blisters or other packaging, tablets, powders, active ingredients and other matrices can be measured. CURRENTA Analytik uses mass spectrometry (MS) to ensure that the high demands on selectivity and sensitivity are met.

Established nitrosamines under GMP conditions

The following nitrosamines are established and can be quantified:

    • N-Nitrosodimethylamine (NDMA)
    • N-Methylethanolamine (NMEA)
    • N-Nitrosodiethylamine (NDEA)
    • N-Nitrosodipropylamine (NDPA)
    • N-Nitrosodibutylamine (NDBA)
    • N-Nitrosopiperidine (NPIP)
    • N-Nitrosopyrrolidine (NPYR)
    • N-Nitrosomorpholine (NMOR)
    • N‐Nitrosomethylphenylamine (NMPhA)
    • N-Nitrosomethybenzylamine (NMBenzA)

The limit of determination depends on the initial weight and is 20ppb for 1g. Other special nitrosamines can be detected after consultation. Please contact us.
An accredited and extensively validated method exists under DIN ISO 17025 conditions; customers can already commission this method for an initial assessment of their pharmaceutical products.

 

x CURRENTA CURRENTA zum Home-Bildschirm hinzufügen:
drücken und dann Zum Home-Bildschirm.