Analysis contents | Analysis Standard: BP(2016) | Analysis results | |
Appearance and solubility | White or almost white, crystalline powder. It has a sweet taste.Freely soluble in water, sparingly soluble in ethanol (96%) | Qualified | |
Identification | Positive | Positive | |
Appearance of solution | The Solution is clear and not more intensely colored than reference solution BY7 | Qualified | |
Assay | ≥99.5% | 99.90% | |
Acidity or alkalinity | 6.0g sample 0.1M NaOH≤0.15ml | 0.05ml | |
Specific optical rotation | +52.5º to +53.3º | 52.9º | |
Foreign sugars,soluble starch,dextrins | Qualified | Qualified | |
Sulphites | Maximum 15ppm SO2 | <15ppm SO2 | |
Chlorides | Maximum 125ppm | <25ppm | |
Sulphates | Maximum 200ppm | <25ppm | |
Arsenic | Maximum 1ppm | <0.25ppm | |
Barium | Any opalescence in the solution is not more intense than in the standard | Qualified | |
Calcium | Maximum 200ppm | <50ppm | |
Lead | Maximum 0.5ppm | <0.5ppm | |
Water | Maximum 1.0% | 0.10% | |
Sulphated ash | Maximum 0.1% | 0.01% | |
Endotoxin | <1.25Eu/g | <1.25Eu/g | |
Bacilli | Maximum 1000cfu/g | <10 cfu/g | |
Mold | Maximum 100cfu/g | <10 cfu/g | |
E.coli | Not available | Negative |