| ≥1 piece |
|
Basis |
Correspond to BP2007 |
||
|
ITEM |
STANDARD |
RESULT |
CONCLUSION |
|
Appearance |
White crystalline powder |
White crystalline powder |
Conformity |
|
Identification A: Infrared absorption spectrophotometry |
Conformity |
Conformity |
Conformity |
|
Identification B: Melting point |
165°C~170°C |
165.9°C~167.9°C |
Conformity |
|
Identification C: TLC |
Conformity |
Conformity |
Conformity |
|
Identification D: Specific optical rotation |
+23°~ +25° |
+23.3° |
Conformity |
|
Appearance of solution |
Clear and colourless |
Clear and colourless |
Conformity |
|
Conductivity |
≤20us/cm |
4.9us/cm |
Conformity |
|
Reducing sugars |
≥12.8 ml |
17.7ml |
Conformity |
|
Related substances: The area of any peak Total impurities |
≤2% ≤2% |
<2% <2 % |
Conformity |
|
Lead |
≤0.5 ppm |
<0.5 ppm |
Conformity |
|
Nickel |
≤1 ppm |
<1 ppm |
Conformity |
|
Loss on drying |
≤0.5% |
0.2% |
Conformity |
|
Microbial contamination: TAMC TYMC Escherichia coli Salmonella |
≤100 CFU/g ≤100 CFU/g Negative Negative |
<10 CFU/g <10 CFU/g Negative Negative |
Conformity |
|
Bacterial endotoxins |
<2.0EU/g |
<2.0 EU/g |
Conformity |
|
Assay |
98.0% ~ 102.0% |
99.6% |
Conformity |