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Sertraline HCL & Venlafaxine HCL



Sertraline HCL & Venlafaxine HCL

Product Code : 15

Product Specification

 
 Product Name :  SERTRALINE HYDROCHLORIDE

   

 
S.No.
 
          TEST            SPECIFICATION                   RESULT 
 
         SPECIFICATION            SPECIFICATION                   RESULT 
 

        RESULT

 
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Description          

Solubility 
 
 
 
 

Identification 
 

Melting Range 
 

Clarity (1% in Dimethyl  sulphoxide )  

Specific optical rotation (at 250C) 

Heavy metal

       

 
A white to off  white  crystalline powder. 

soluble in dimethylsulphoxide and sparingly soluble in methanol & Dimethylformamide. 

By IR Spectroscophy

Clear and colourless 

bet.240.0 0C  to  250.00C  
 

        Clear solution. 
 

    Bet. +370C  to  +420C 

        

           NMT 20 ppm

 
white  crystalline powder 

Complies 
 
 
 

    Conformed  
 

245.0 0C to  248.0 0C 
 
 

    Complies 

    +40.86 % 
 

       Complies

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S.NO
 

TEST                            

 
  SPECIFICATION            SPECIFICATION                   RESULT 
 

   RESULT

 
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Related Substance

( By HPLC)

  

Sulphated ash        

Loss on drying 

Assay       

 

Single Impurity NMT 0.5 % 

Total Impurity    NMT 1.0 % 

       NMT 0.10 % w/w

            

       NMT 0.50 % 

Bet. 99.0% to 101.0% w/w

     (Calculate on dry basis)

 

             0.18 % 

  0.25 % 

       0.07 % w/w 

0.32 % 

99.75 %

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