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            Certificate of Analysis        

Hydroxypropyl Methylcellulose 2910 USP30 (E-15)

BATCHNUMBER

     201103013   

TEST DATE

  03-13-2011         

QUANTITY

      Sample     

MANUFACTURE DATE

  03-12-2011        

PACKING

    25kg / barrel  

EXPIRATIONDATE

  03-11-2014         

 

  TEST 

   SPECIFICATION 

     RESULT 

Appearance

White or off-white powder, no visible                             evidence of contamination by foreign matter

 

   conforms       

Identification

Conform

    Conforms     

PH

5.5 ­— 7.5

    PH 6.6        

Viscoisty

12.0—18.0 cp.s

    17.0 cp.s       

Water-insoluble Substances

Not More Than  0.5%

    0.2 %         

Loss on drying

Not More Than  5.0%

    2.4 %         

Residue on ignition

Not More Than  1.5%

    0.7 %         

Heavy Metal

Not More Than  0.001%

    <0.001 %     

Arsenic

Not More Than  0.0002%

    < 0.0002 %   

Whiteness

Min80

      81.6        

Methoxy

28.0% to 30.0% CH3O Calculated on the anhydrous basis

     28.1 %      

Hydroxypropoxy

7.0% to 12.0% C3H7O2 Calculated on the anhydrous basis

     7.6 %       

Bioburden

 

 

Total Microbial Count

Not More Than 1000CFU/gram

     Conforms    

Total Mold and Yeast

Not More Than 100CFU/gram

     Conforms    

Escherichia Coli         

Negative

    Not Detect   

 

Analysts:                              Checker:                           Supervisor:                      

FINAL BATCH DISPOSITION

                                                                           By:                 

     Approved                            Rejected

Manufactured By: Huzhou Zhanwang Pharmaceutical Co. Ltd