Product Name
|
Cephradine with L-Arginin
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Shelf Life
|
3 years
|
Test
|
Specification
|
Result
|
Identification
|
Meets the requirements
|
Meets the requirements
|
pH
|
8.0-9.6
|
8.7
|
Loss on drying
|
≤5.0%
|
2.4%
|
Assay of Cephradine (on anhydrous basis)
|
|
|
Visible Particles
|
Meets the requirement
|
Meets the requirement
|
Particulate Matter
|
≤3000 particles (≥10um)
|
Particles: 126
|
Microscopic particle count test
|
≤300 particles (≥25um)
|
Particles: 0
|
Assay of Cephalexin
|
≤5.0%
|
1.4%
|
Sterile
|
Meets the requirements
|
Meets the requirements
|
Conclusion:
|
The product meets the requirements of USP36.
|