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Ondansetron Hydrochloride (IP/BP/USP)

Ondansetron Hydrochloride  (IP/BP/USP)
Ondansetron Hydrochloride (IP/BP/USP)
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Product Code : BD 04
Product Description

SR.

No

TEST

SPECIFICATIONS

1.        

 Description

White or almost white powder

2.        

Solubility

Sparingly soluble in water and in alcohol.

Soluble in methanol.

Slightly soluble in MDC.

3.        

Identification

(A) IR-The infra red absorption spectrum of  the test sample exhibits  maximum only at the same wavelengths as that of the working standard

(B)Chloride Test

4.        

Sulfated Ash

NMT 0.1%

5.        

Water

9.0 to 10.5%

6.        

Related Substance by HPLC   

 

 

I.  Impurity C                  :  NMT 0.2%                                                    

II  Impurity D                  :  NMT 0.1%                                                          

III  Imp A                        :  NMT 0.2%                                         

IV Imidazole                   :  NMT 0.2%    

V 2-Methyl imidazole     : NMT 0.2%                      

VI Other impurity            :  NMT 0.1%

VII Total impurity           :NMT 0.5%

7.        

Assay (By HPLC)  On dry basis

98 – 102.0 %


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