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Срок поставки: | 1 дней |
Модель: 6700-34-1
Product name | Dextromethorphan Hydrobromide | ||
CAS No. | 6700-34-1 | Outer Packing | 25KG /drum |
Production date | 2016.05.24 | Shelf life | 2020.05.23 |
Standard adopted | USP38/EP8 | ||
Items of analysis | Secification | Results | |
Apperance | Practically white crystal or crystalline powder | White crystalline powder | |
FT-IR | The sample spectrum correspond to that of the reference standard | Conforms | |
UV | Not more than 3.0% difference of RS(on anhydrous basis) | 1.4% | |
Bromide Test | Yellow white precipitate forme | Conforms | |
Specific rotation A | 1.8W/V in water: Not more than 1.0%difference of RS | 0.2% | |
Specific rotation B | 2.0%w/V in 0.1M HCl: +28ºCTO +30ºC at 589nm and 20ºC(on anhydrous basis) | +28.9ºC | |
Clarity of solution | 5.0%w/V in alcohol: Clear and colorless | Conforms | |
pH | 5.2-6.5(1 in 100 water solution) | 5.9 | |
Acidity or Alkalinity | Not more than 0.4ml of 0.01M HCLconsumed | 0.30ml | |
Water(by KF Titration) | 4.0%-5.5% | 4.8% | |
impurities A, B, C, D | For each of impurities A, B, C, D not more than 0.5% | Impurities A, B, C, D; Not detected. | |
impurities A, B, C, D | Among impurities A, B, C, D not more than one greater than 0.25% | 0 | |
For each of unspecified impurities | not more than0.10% | <0.05% | |
Total impurities | not more than 1.0% | <0.05% | |
Residue on Ignition | Not more than 0.1% | 0.07% | |
N, N-Dimethylaniline | Not more than 0.001% | Conforms | |
Phenolic compounds | No blue-green color develops | Conforms | |
Assay A (by HPLC) | 98.0%~102.0%(on anhydrous basis) | 99.9% | |
Assay B(by titration) | 99.0%~101.0%(on anhydrous basis) | 100.4% | |
Methanol | ≤3000ppm | N. D | |
≤890ppm | 76.5ppm | ||
Acetone | ≤5000ppm | Conforms | |
Storage | Preserve in tight containers; protected from light | Conforms | |
Conclusion | Qualified |
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Группа Продуктов : Фармацевтические Интермедиаты