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 |
+ 52.5 º-+ 53.3 º |
+ 53.0 º |
|
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 |
≤ 15ppmSO 2 |
<15ppmSO 2 |
|
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 swe a t |
P ass |
2 |
Specific rotation |
+52~53.5degree |
53.2 degree |
3 |
Acidity (ml) |
1.2max |
0. 15 |
4 |
De-Equivalent |
99.5%Min |
99.8 8 % |
5 |
Chloride, % |
0.02max |
0.001 |
6 |
Sulphate, % |
0.02max |
0.01 |
7 |
I nsoluble matter in alcohol |
Clear |
Clear |
8 |
S ulfite and soluble starch |
Y ellow |
Yellow |
9 |
Moisture, % |
9. 5 max |
8.8% |
10 |
Ash , % |
0.2max |
0.0 5 |
11 |
I ron, % |
0.002max |
0.0004 |
12 |
Heavy metal, % |
0.002max |
0.000 3 |
13 |
A rsenic, % |
0.0002max |
0.0001 |
14 |
C olor dots, cfu/50g |
50max |
25 |