At GVK BIO, we have expertise to develop sensitive analytical methods for Nitrosamine impurity quantification using GCMS or LCMSMS for both finished products and APIs. The specifications of the analytical method will be in accordance to requirements all regulatory bodies across globe including USFDA.
1. | N-Nitrosodimethylamine (NDMA) |
2. | N-Nitrosodiethylamine (NDEA) |
3. | N-Nitrosoethylisopropylamine (NEIPA) |
4. | N-Nitrosodiisopropylamine (NDIPA) |
5. | N-Nitrosodibutylamine (NDBA) |
6. | N-Nitrosomethyl-4-amino-butyric acid (NMBA) |
We design protocols to drive method development, method validation and finished product samples which is suitable for regulatory filing requirements across the globe.