Specification F 02
Fluridil®
2-hydroxy-2-methyl-N-[4-nitro-3-(trifluoromethyl)phenyl]-3-(2,2,2-trifluoroacetylamino) propanamide
Molecular Formula: C13H11F6N3O5
Molecular Weight: 403.23
Description: Light yellow-greenish powder or light yellow to yellow powder.
| Tests: | Limits: | Methods: |
| Identification: I.R. spectrum | Ph. Eur. 5th Ed., <2.2.24> | |
| Water (K.F.): | max. 0.2 % | Ph. Eur. 5th Ed., <2.5.12> |
| Purity (HPLC): | Ph. Eur. 5th Ed., <2.2.29> | |
| Impurity A | max. 0.3 % | NQ F 02, test No. 3 |
| Impurity B | max. 0.05 % | NQ F 02, test No. 4 |
| Impurity C | max. 0.05 % | NQ F 02, test No. 5 |
| Total sum of impurities: | max. 0.5 % | NQ F 02, test No. 6 |
| Any other individual impurity: | max. 0.05 % | NQ F 02, test No. 7 |
| Assay (HPLC, calculation based on dry substance and external standard): | 98.0 – 102.0 % | Ph. Eur. 5th Ed., <2.2.29> NQ F 02, test No. 8 |
| Methanol (GC): | max. 300 ppm | NQ F 02, test No. 9 Ph. Eur. 5th Ed., <2.2.28> |
| Heptane (GC): | max. 1000 ppm | NQ F 02, test No. 10 Ph. Eur. 5th Ed., <2.2.28> |
| 2-propanol (GC): | max. 1000 ppm | NQ F 02, test No. 11 Ph. Eur. 5th Ed., <2.2.28> |
| Loss on drying (95 °C): | max. 0.5 % | Ph. Eur. 5th Ed., <2.2.32> |
| Shelf life: 2 years (to be understood as a retest date) | ||
A- N-[(4-nitro-3-trifluoromethyl)-fenyl]-2-methyl-2-hydroxy-3-aminopropanamide
B- 4-nitro-3-trifluormethyl aniline
C- N-[(4-nitro-3-trifluoromethyl)-fenyl]-2-methyl-2,3-dihydroxypropanamide
*NQ = Norm of Quality
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