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磷霉素钠/26016-99-9/质量信息COA

Certification of analysis

Product Name

Fosfomycin Sodium EP7

Packing

50kg/fiber drum

Product Grade

Non-sterilr

Batch No

20220501

Test Date

May.06,2022

Quantity

500kg

Report Date

May.06,2022

MFG Date

May.05,2022

Tested Standard

EP7

Exp.Date

May.04,2024

     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)

Conclusion:tested according to EP7, meet the standard requirements.

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