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Testing items
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|
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Appearance
|
Almost white crystalline powder
|
|
Identification
|
Meets the requirements
|
|
Appearance of solution
|
≤0.20
|
|
Specific Rotation
|
58°- 64°
|
|
PH
|
4.5-6.5
|
|
Crystallinity
|
Meets the requirements
|
|
Loss on drying
|
≤3.0%
|
|
Related substances
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Any individual impurity≤1.0%
|
|
Sum of all impurity≤3.0%
|
|
|
N.N-Dimethylaniline
|
≤20ppm
|
|
2-ethylhexanoic acid
|
≤0.5 per cent
|
|
Bacterial Endotoxins
|
≤0.20EU/mg
|
|
Sterility
|
Meets the requirements
|
|
Assay
|
Not less than 916μg and not more than 964μg of Cefotaxime per mg
|
