Dear Sir,
What LOD is acceptable for these compounds?
We can keep LOD as 10 %, Typical example is provided below for reference:
| XYZ API MDD (in mg): | 500 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sr. No | Name of N-Nitrosamine | (Impurity Code) Provided in guideline of | AI (ng/day) | Limit | LOD in ppm | LOQ in ppm | LOD in ppb | LOQ in ppb | ||||
| EMA | CA | US | BZ | in ppm | in ppb | 10% | 30% | 10% | 30% | |||
| 1 | N-Nitrosodiisopropylamine, | DIPNA | NDIPA | NDIPA | DIPNA | 26.5 | 0.053 | 53.000 | 0.005 | 0.016 | 5.300 | 15.900 |
| 2 | N-Nitrosoethylisopropylamine / N-Nitrosoisopropylethylamine (US) | EIPNA | NEIPA | NIPEA | EIPNA | 26.5 | 0.053 | 53.000 | 0.005 | 0.016 | 5.300 | 15.900 |
| 3 | N-Nitroso-di-n-butylamine | NDBA | NDBA | NDBA | 26.5 | 0.053 | 53.000 | 0.005 | 0.016 | 5.300 | 15.900 | |
| 4 | N-Nitrosodiethylamine | NDEA | NDEA | NDEA | NDEA | 26.5 | 0.053 | 53.000 | 0.005 | 0.016 | 5.300 | 15.900 |
| 5 | N-Nitrosodipropylamine | NDPA | NDPA | NDPA | 26.5 | 0.053 | 53.000 | 0.005 | 0.016 | 5.300 | 15.900 | |
| 6 | N-Nitroso-N-methylaniline / phenylmethylnitrosamine | NMPA | NMPA | 34.3 | 0.069 | 68.600 | 0.007 | 0.021 | 6.860 | 20.580 | ||
| 7 | N-Nitrosodimethylamine | NDMA | NDMA | NDMA | NDMA | 96.0 | 0.192 | 192.000 | 0.019 | 0.058 | 19.200 | 57.600 |
| 8 | N-Nitroso-N-methyl-4-aminobutyric acid / carboxypropylmethylnitrosamine | NMBA | NMBA | NMBA | NMBA | 96.0 | 0.192 | 192.000 | 0.019 | 0.058 | 19.200 | 57.600 |