Behandlung des Meniere-Syndroms Betahistin-Dihydrochlorid
Basisinformation
Modell: USP
Produktbeschreibung
EINECS Nr .: 226-966-5
Standard:USP30 \ nAssay: 99.0 ~ 101.0% \ n \ nMF: C8H14Cl2N2 \ Ursprungsort: China (Festland) \ nVerpackungsdetails: 25kg Trommel \ n \ n \ nGEBRAUCH: \ nVerwendet in der Behandlung von Meniere-Syndrom, zerebrale Arteriosklerose, Gehirn und Bluthochdruck durch Schwindel, Erbrechen und Tinnitus verursacht. \ nCOA :
ITEMS | SPECIFICATION | RESULTS |
Appearance | White to almost crystalline powder, very hygroscopic | Conforms |
Assay | 99.0%-101.0% | 99.75% |
Ph | 2~3 | 2.5 |
Loss on drying | Not more than 1.0% | 0.3% |
Sulphated ash | Not more than 0.1% | 0.06% |
Identification | IR: Similar to the reference standard HPLC: Similar to the reference standard | Conforms |
| Residual solvents (2-propanol) | Not more than 0.5% | 0.20% |
Solubility | Very soluble in water Freely soluble in alcohol (96%) Practically insoluble in 2-propanol | Conforms |
Clarity of solution | (0.1g in 10ml carbon dioxide free water)-clear | Conforms |
2-(2-Hydroxyethyl)pyridine | Not more than 0.2% | Not detected |
2-Vinylpyridine | Not more than 0.2% | 0.06% |
| N-Methyl-N,N-bis(2-Pyridin-2-Yl-ethyl) amine | Not more than 0.2% | 0.13% |
Other individual impurity | Not more than 0.1% | Conforms |
Total impurities | Not more than 0.5% | 0.3% |
Conclusion: It conforms to the USP30 STANDARD. | ||
Produktgruppe : Pharmazeutischer Bestandteil > API für Herz-Kreislauf-und Blut-System-Medikament
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