|
Specification
|
USP 36
|
|
Items
|
Specification
|
Test results
|
|
Appearance
|
White to almost white crystalline powder
|
White crystalline powder
|
|
Identification
|
IR: Should comply with reference standard
|
Complies
|
|
HPLC: Should comply with reference standard
|
Complies
|
|
Water
|
NMT 0.5%
|
0.15%
|
|
Sulphated ash
|
NMT 0.2%
|
NMT 0.2%
|
|
Heavy meatals
|
NMT 0.002%
|
NMT0.002%
|
|
Limit of Azide
|
NMT 10ppm
|
NMT 10ppm
|
|
Related compounds A
|
NMT 0.2%
|
0.002%
|
|
Any other individual impurity
|
NMT 0.1%
|
0.004%
|
|
Total impurities
(excluding R-isomer)
|
NMT 0.5%
|
0.15%
|
|
Residual solvents
|
Ethanol: NMT 5000 ppm
|
28ppm
|
|
Dichloromethane: NMT600 ppm
|
Not detected
|
|
D, D-dimethylformamide NMT880 ppm
|
Not detected
|
|
t-butyl methyl ether NMT5000 ppm
|
Not detected
|
|
Xylene: NMT1500ppm
|
320ppm
|
|
Toluene: NMT890ppm
|
Not detected
|
|
Assay (HPLC)
|
98.0~102.0%
|
99.9%
|
|
Conclusion
|
It Complies with USP36
|
