Tipo de Pago: | L/C, T/T, D/P, Paypal |
---|---|
Cantidad de pedido mínima: | 1 |
Modelo: bp ep usp
Test items | Standard | Test results |
Description | White or almost white crystalline powder | white crystalline powder |
Solubilit | Slightly soluble in water ,very slightly soluble in methanol, practically insoluble in ethano | Complies |
Identificatio | IR vs standard | Complies |
Test for specific optical rotation | Complies | |
Appearance of solution | The solution is clear and colorless | Complies |
Acidity | Not more than 0.6ml of 0.01M Naoh is required to change the color of the indicator to pink | 0.44ml |
Specific optical rotatio | +74.5°~+78.0° | +75.6° |
Related substances | ImpurityA:NMT0.1% | 0.03% |
Impurity B: NMT0.1% | 0.05% | |
Impurity C: NMT0.1% | 0.03% | |
Any other impurity:NMT0.1% | 0.05% | |
Total of other impurities:NMT0.1% | 0.06% | |
Total of impurities:NMT0.3% | 0.16% | |
Impurity D | NMT0.1% | 0.01% |
Silver | NMT5ppm | <1ppm |
Loss on drying | NMT0.5% | 0.19% |
Assay | 98~102% (dried substance) | 99.85% |
Bacterial endotoxins | <1.0IU/mg | Complies |
Grupos de Producto : Ingrediente farmacéutico > Otro ingrediente farmacéutico