The measuring of very low concentration elemental impurities is usually a mandatory part, described in ICH-Q3D and <232-233>.
Possible contaminations in drug-products can originate from used materials and catalysts. With fillers they can occur as natural contaminations. Brightlabs had validated methods available to properly analyse the strict standards.
Brightlabs has developed an internal method (GC-MS/MS) for the measuring of Nitrosamines.
Depending on the matrix measurements can be made on a concentration of 10 ppb.
The current methods contain the following nitrosamines:
- N-nitrosodimethylamine (NDMA)
- N-nitrosomethylethylamine (NMEA)
- N-nitrosodiethylamine (NDEA)
- N-nitroso-di-n-propylamine (NDPA)
- N-nitrosomorpholine (NMOR)
- N-nitrosopyrollidine (NPYR)
- N-nitrosopiperidine (NPIP)
- N-nitrosodi-n-butylamine (NDBA)
Brightlabs has a standard headspace method for the analysis of residual solvents, such as described in Ph. Eur 5.4.
Pharmaceutical products have traces of volatile organic substances that are used during the production of medicines and remain afterwards. The presence of residual solvents has to be carefully monitored and limited, because even traces of these solvents could influence the safety and efficacy of medication.
With our method we can analyse practically all class 2 & 3 for the mentioned limits in the Ph.Eur. For the remaining volatile organic substances, or customer specific substances, please contact us for the possibilities.