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Product name:Tropine
CAS#: 120-29-6
EINECS#: 204-384-2
Molecular formula: C8H15NO
Molecular weight:141.21
Appearance:white powder
Use:Pharmaceutical intermediate
| Item | Specifications | Results |
| Appearance | A white crystalline powder | white crystalline powder |
| Identification | A.The solution appears purple | Conforms |
| B.IR:consistent with the spectrum obtained with .Rimantadine Hydrochloride RS | ||
| C.Specific Reaction of chloride | ||
| PH | 4.5-6.5(1% solution in water) | 4.93 |
| Clarity of solution | Solution of substance must stand the comparison with etalon I | Conforms |
| Color of solution | Color of solution must stand the comparison with etalon Y7 | Conforms |
| Sulphates | NMT0.05% | Conforms |
| Toluene | NMT890ppm | Not detected |
| Methanol | NMT3000ppm | Not detected |
| Related substances (TLC) | NMT1.0% | Conforms |
| Loss on drying | NMT0.5% | 0.07% |
| Sulphated ash | NMT0.1% | 0.09% |
| Ammonium | NMT0.08% | Conforms |
| Heavy metals | NMT0.001% | Conforms |
| Assay(On dry basis) | 99.0%-101.0% | 99.58% |
| Solubility | Freely Soluble in Chloroform and methanol, soluble in 95% ethanol an water. | Conforms |
| Microbiology | Total bacterial count:<1000CFU/g | 30CFU/g |
| Total Fungus count: <100CFU/g | <10 CFU/g | |
| Escherichia coli:Not detected | Not detected | |
| Conclusion | The results conforms with Russian Registration Specification. | |
