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Certification of analysis
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Product Name |
Fosfomycin Sodium EP7 |
Packing |
50kg/fiber drum |
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Product Grade |
Non-sterilr |
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Batch No |
20220501 |
Test Date |
May.06,2022 |
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Quantity |
500kg |
Report Date |
May.06,2022 |
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MFG Date |
May.05,2022 |
Tested Standard |
EP7 |
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Exp.Date |
May.04,2024 |
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Items Standard Result Conclusion
Characteristic White hygroscopic powder White hygroscopic poeder Conforms
Identification Positive Positive Conforms
Test
pH 9.0~10.5 9.1 Conforms
Specific Optical Rotation -13.0°~-15.0° -13.4° Conforms
Clear ≤1# ＜1# Conforms
Color ≤B9 ＜B9 Conforms
Water(%) ≤1.0% 0.9% Conforms
1,2-Dihydroxylpropyl- ≤1.0% 0.9% Conforms
Phosphenate
Heavy metals ≤20ppm ＜20ppm Conforms
Assay 95.0%~101.0% 98.1% Conforms
(On the anhydrous basis)
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Conclusion：tested according to EP7, meet the standard requirements. |
