|
Items of Test |
Limits of Test |
Results of Test |
|
1.Appearance |
Orange yellow crystalline powder(USP) |
Meets |
|
2.Indentification |
Positive |
Meets |
|
3.Acidity or Alkalinity |
Check the color of the test solution
After adding the respective solutions |
Meets |
|
4.Lumiflavin |
Absorbance of the filtrate at 440nm
Does not exceed 0.025(USP);not
more intense than BY6(EP/BP) |
0.009
Meets |
|
5.Absorbance |
0.31 – 0.33 A375nm/A267nm
0.36 – 0.39 A444nm/A267nm
|
0.32/0.38 |
|
6. Partical Size |
100%passes through 60 mesh sieve
|
Meets |
|
7. Specific Rotation |
between-115°and-135°(EP/BP/USP) |
121°(USP)
129°(EP/BP) |
|
8.Loss on Drying |
≤1.5%
|
0.8% |
|
9. Heavy Metals |
<10ppm
|
Meets |
|
10. Residue on Ignition |
≤0.03%(USP)
≤0.1%(EP/BP)
|
0.1% |
|
11.Organic Volatile Impurities |
Method IV<467>(USP)
|
Meets |
|
12. Assay(on dried basis) |
98.0% - 102.0%(USP)
97.0% - 10.3.0%(EP/BP)
|
99.6% |
