| ≥1 piece |
|
Item
|
Specification
|
Test result
|
|
Characters
|
A white or almost white crystalline powder
|
A white crystalline powder
|
|
Infrared spectrum
|
To match with the working standard
|
Complies
|
|
Water
|
Not more than 5.0%
|
4.15%
|
|
Residual solvents
|
Meets the requirements
|
Complies
|
|
Specific rotation
|
-40.0° -43.4°
|
-40.4°
|
|
Related substances
|
Not more than 2.0%
|
1.27%
|
|
Lead
|
Not more than 2ppm
|
Complies
|
|
Residue on ignition
|
Not more than 0.1%
|
0.1%
|
|
Assay
|
97.0%102.0%
|
98.73%
|
|
PH
|
5.07.0
|
5.44
|
|
Melting Point
|
8185
|
80.983.4
|
|
Total Aerobic Bacteria
|
250cfu/g
|
120cfu/g
|
|
Coliform
|
10mpn/g
|
Complies
|
|
Fungi
|
100cfu/g
|
Complies
|
|
Solubility (25)
|
100g per 100g of ethanol
|
Complies
|
|
1.3g per 100g of water
|
Complies
|