Control of nitrosamine impurities in medicines
Nitrosamines, as we have already mentioned in previous communications, are present in different products and especially in pharmaceutical compounds. For this reason these impurities should be detected and controlled in order to avoid harmful effects on human health, which have been observed after prolonged intake of certain medicines.
Companies authorised to market medicines in the EU must carry out and submit risk assessments to identify active substances or final products at risk of N-nitrosamine formation or cross-contamination.
The deadline for performing and submitting risk assessments for chemical medicines was 31 March. July 1st is the deadline for biological medicines.
We provide you with the references that will help you to detect these compounds in the laboratory:
USP standards
45-1466674N-Nitrosodimethylamine (NDMA) (1 mg/mL in methanol)
45-1466652N-Nitrosodiethylamine (NDEA) (1 mg/mL in methanol)
45-1466663N-Nitrosodiisopropylamine (NDIPA) (1 mg/mL in methanol)
45-1466641N-Nitrosodibutylamine (NDBA) (1 mg/mL in methanol)
45-1466685N-Nitrosoethylisopropylamine (NEIPA) (1 mg/mL in methanol)
45-1466696N-Nitrosomethylaminobutyric Acid (NMBA) (1 mg/mL in acetonitrile)
Reagecon Standards
07-RENIT001-1mlN-Nitrosodiethylamine 1000 µg/mL in Purge & Trap Methanol
07-RENIT002-1mlN-Nitrosodiethylamine 2000 µg/mL in Purge & Trap Methanol
07-RENIT003-1mlN-Nitrosodimethylamine 1000 µg/mL in Purge & Trap Methanol
07-RENIT004-1mlN-Nitrosodimethylamine 2000 µg/mL in Purge & Trap Methanol
07-RENIT005-1mlN-Nitrosodi-n-propylamine 1000 µg/mL in Methylene Chloride
07-RENIT006-1mlN-Nitrosodi-n-propylamine 2000 µg/mL in Methylene Chloride
07-RENIT007-1mlN-Nitrosodiphenylamine 1000 µg/mL in Methylene Chloride
07-RENIT008-1mlN-Nitrosodiphenylamine 2000 µg/mL in Methylene Chloride
07-RENIT009-1mlN-Nitrosomethylethylamine 1000 µg/mL in Purge & Trap Methanol
07-RENIT010-1mlN-Nitrosomethylethylamine 2000 µg/mL in Purge & Trap Methanol
07-RENIT011-1mlN-Nitrosomorpholine 1000 µg/mL in Purge & Trap Methanol
07-RENIT012-1mlN-Nitrosomorpholine 2000 µg/mL in Purge & Trap Methanol
07-RENIT013-1mlN-Nitrosopiperidine 1000 µg/mL in Purge & Trap Methanol
07-RENIT014-1mlN-Nitrosopiperidine 2000 µg/mL in Purge & Trap Methanol
07-RENIT015-1mlN-Nitrosopyrrolidine 1000 µg/mL in Purge & Trap Methanol
07-RENIT016-1mlN-Nitrosopyrrolidine 2000 µg/mL in Purge & Trap Methanol
These nitrosamine standards are a tool that will help you in the quantification of nitrosamine impurities, with the advantage that the analysis can be carried out by the main LC/MS and GC/MS techniques as well as the application in different methods.
If you would like more information on how the European Medicines Agency manages this issue of interest to many companies in the pharmaceutical sector we provide this link.
