Specification No. B 14
BP-735
4-(((butylamino)thioxomethyl)amino)-2-(trifluoromethyl)benzenecarbonitrile
Molecular Formula: C13H14F3N3S
Molecular Weight: 301.34
Description: Slightly yellow, white to off-white hydrophobic powder. Freely soluble in acetone and dimethylformamide, soluble in methanol and practically insoluble in water.
| Tests: | Limits: | Methods: |
| Identification: I.R. spectrum | USP 28 <197> | |
| Water (K.F. titration): | max. 0.5% | USP 28 <921> method I |
| Purity (HPLC): | USP 28 <621> | |
| 4-cyano-3- trifluoromethylphenylisothiocyanate: |
max. 0.1% Area | NQ B14, test No. 3 |
| Any other individual impurity: | max. 0.1% Area | NQ B14, test No. 4 |
| Total sum of all impurities: | max. 0.5% Area | NQ B14, test No. 5 |
| Assay (HPLC, calculation based on dry substance and external standard): |
98.0 - 102.0% |
USP 28 <621> NQ B14, test No. 6 |
| Melting point (melting range does not exceed 3°C) |
min. 105 °C | USP 28 <741> |
| Heavy metals (calculation as lead): | max. 20 ppm | Ph. Eur. 5th Ed., <2.4.8> |
| Residue on ignition: | max. 0.1% | USP 28 <281> |
| Ethyl acetate (GC): |
max. 200 ppm |
USP 28 <621> NQ B14, test No. 10 |
| 2-propanol (GC): |
max. 1500 ppm |
USP 28 <621> NQ B14, test No. 11 |
| Toluene (GC): |
max. 100 ppm |
USP 28 <621> NQ B14, test No. 12 |
| Microbiological test: | ||
| Bacteria | max. 1000 cfu/g | USP 28 <61> |
| Fungi | max. 100 cfu/g | USP 28 <61> |
| Escherichia coli | absent | USP 28 <61> |
| Staphylococcus aureus | absent | USP 28 <61> |
| Salmonella | absent | USP 28 <61> |
| Pseudomonas aeruginosa | absent | USP 28 <61> |
| Shelf life: 6 months (to be understood as a retest date) | ||
This specification supersedes the specification No. B14, version 1 issued on March 20, 2006.
*NQ = Norm of Quality
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