Certificate ofAnalysis

Product Name: DOXYCYCLINE HYCLATE            Specification:25/kgdrum

Batch No.:A20100631                                     Batch Quantity:475kg

Manu.Date:2010.06.28                                   ReportDate:2010.07.02            

RestestDate:2014.06.27                                Testing Basis: EP6.0 BP2007.

TEST                 SPECIFICATION                         RESULT

1.Characters            yellow crystallinitypowder                Complies

2.Identification         a)Sulphurie acid reaction ayellow

 colourdevelops                         Complies 

b)HPLC                               Complies

c)Itgivesreactionofchlorides               Complies

3.PH                  2.0—3.0                              2.5

4.Specific Absorbance    300--335                              322

5.Specific optical rotation  -105°--120°                          _-112°

6.Heavymetals         ≤50ppm                               <50ppm

7.Light-absorbing impulse  At 490nm≤0.07                        0.02

8.Related substances      a)6-cpidocycycline                      1.5%

                      b)metacycline                          0.5%

                      c)4-epldoxyxyxline                          not found

                      d)4-epi-6-epidoxycycline                  not found

                      e)oxyteracycline                              not found

                      f)ADOT≤0.5%                                  not found

                      g)any otherimpurities≤0.5%             notfound

                      h)not identifiedimpurities≤0.1%        notfound

9.Ethanol               4.3—6.0%(m/m)                         5.1%

10.Sulphatedash         ≤0.4%                                 0.09%

11.Water                1.4%—2.8%                             1.9%

12.Assay                95.0%—102.0%                          97.4%

Conclusion:The above product contorms to EP6.0 BP2007.

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