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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 |