Items of Analysis | Analysis standard | Analysis results | |
Appearance | A white, crystalline, with a sweet taste ,freely soluble in water ,sparingly soluble in alcohol | Qualified | |
Identification | |||
A: Specific optical rotation | +52.5º-+53.3º | +53.0º | |
B: TLC | Complies | Complies | |
C: Chemical test (red precipitate) | Positive | Positive | |
Test | |||
Acidity or alkalinity | 6g sample 0.1mol/L NaOH≤0.15ml | 0.06ml | |
Water | Not more than 1.0% | 0.10% | |
Arsenic | Not more than 1ppm | <0.25ppm | |
Calcium | Not more than 200ppm | <50ppm | |
Lead in sugars | Not more than 0.5ppm | <0.5ppm | |
Chloride | Not more than 125ppm | <25ppm | |
Sulphates | Not more than 200ppm | <25ppm | |
Appearance of solution | Solution is clear and not more intensely colored than reference solution | Qualified | |
Barium | Any opalescence in the solution is not more intense than in the standard | Qualified | |
Sulphites | ≤15ppmSO2 | <15ppmSO2 | |
Foreign sugars,soluble starch,dextrins | Qualified | Qualified | |
Sulphated ash | 0.1% | 0.01% | |
Pyrogens (TAL 10% solution): | 0.125Eu/ml max | 0.125Eu/ml max |
Serial Number | Item | Standard | Inspection Result |
1 | Appearance | White crystal or powder, odorless and a little sweat | Pass |
2 | Specific rotation | +52~53.5degree | 53.2degree |
3 | Acidity (ml) | 1.2max | 0.15 |
4 | De-Equivalent | 99.5%Min | 99.88% |
5 | Chloride, % | 0.02max | 0.001 |
6 | Sulphate, % | 0.02max | 0.01 |
7 | Insoluble matter in alcohol | Clear | Clear |
8 | Sulfite and soluble starch | Yellow | Yellow |
9 | Moisture, % | 9.5max | 8.8% |
10 | Ash, % | 0.2max | 0.05 |
11 | Iron, % | 0.002max | 0.0004 |
12 | Heavy metal, % | 0.002max | 0.0003 |
13 | Arsenic, % | 0.0002max | 0.0001 |
14 | Color dots, cfu/50g | 50max | 25 |