Test Item
|
Specification
|
Results
|
Appearance
|
White to tan powder
|
Yellowish powder
|
Identification:
HPLC
Chemical
|
Positive by retention time
Give the flame reaction as sodium
|
Complies
Complies
|
Clarity of solution
|
Clear or its opalescence is not more pronounced than reference suspension I
|
Clear
|
Color of solution
|
Not more intensely colored than reference solution Y or OY9
|
=Y4
|
pH
|
5.5-7.5
|
7.0
|
Water
|
Not more than 3.0%
|
0.99%
|
Related substances
|
Not more than 3.0%
|
0.92%
|
Residual solvents
Acetone
Tetrahydrofuran
|
Not more than 2.0%
Not more than 1.4%
|
0.33%
1.06%
|
Bacterial Endotoxins
|
Less than 0.20 EU/mg
|
Complies
|
Sterility
|
Meets the requirement
|
Complies
|
Assay
|
Contain C19H16N5NaO7S3 on anhydrous basis not less than 88.7%
|
94.3%
|
Conclusion
|
The above materials are done based on in-house specification and all the testing data meet the established specifications.
|