API

Azithromycin BP/USP/CP 25kgs/drum

Azithromycin      BP/USP/CP  25kgs/drum

Certificate of Analysis

Product Name:Azithromycin dihydrate           Specification:25/kgdrum

Batch No.:A20100516                        Batch Quantity:475kg

Manu.Date:2010.05.21                        Report Date:2010.05.30    

Restest Date:2014.05.20                       Testing Basis:USP26

TEST                  SPECIFICATION                     RESULT

        Characters              White crystallinity powder              Complies

Identification            a)Infrared Absorption

b)HPLC                            Complies

Specific rotation         -45°— -49°                        -47°

Crystallinity            Meets the requirements                 Complies

PH                   9.0—11.0                            10.3

Water                 4.0%—5.0%                          4.3%

Residueonignition       ≤0.3%                               0.08%

Heavy metals          ≤0.0025%                            <0.0025%

Assay                945u/mg—1030u/mg                    952ug/mg

                     Calculated on the anhydrous basis

Conclusion:The above product contorms to USP26.

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