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Cilostazol
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Cilostazol

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India

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Miembro Básico

Persona de contacto Mr. Sanjay

SF-12, shrinathji arcade, ankleshwar, Anklesvar, Gujarat

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Especificaciones del producto

Descripción del producto

                 SPECIFICATION
 

Test Requirements Results
Appearance White to off-white crystals White crystals
Identification
  1. By IR                                             
 
  1. By HPLC
 
IR spectrum of sample should match with that of working standard.
Retention time of major Peak in sample should match with that of standard.
 
Complies
 
Complies
Solubility Freely soluble in chloroform; slightly soluble in methanol and in alcohol; practically insoluble in water. Complies
Loss on drying Not more than 0.*5% w/w 0.*2%  w/w
Chloride Not more than 0.**8% w/w Complies
Residue on ignition Not more than 0.*0% w/w 0.*7%  w/w
Heavy metals Not more than0.**1% Less than 0.**1%
Related substance
Individual impurity
Total impurities
 
Not more than 0.*0%
Not more than 0.*0%
 
0.*3%
0.*7%
Assay
(By HPLC)
Not less than *8% w/w and not more than **2% w/w *9.*8% w/w
Additional Test
Residual Solvent (By GC)
Methanol
Toluene
IPA
 
Not more than ***0 ppm
Not more than **0 ppm
Not more than ***0 ppm
 
Not Detected
Not Detected
**6 ppm
Conclusion The material complies with respect to the above specification
 

País: India
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Productos relacionados Niksan pharmaceutical

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