BENFOTIAMINE INHOUSE
TESTSSPECIFICATIONS
DescriptionA white to off white crystalline powder
SolubilityIt should slightly soluble in water,Slightly soluble in methanol,Very slightly in alcohol,Insoluble in ether & chloroform
Identification
A)By HPLCA)The principal peak in the chromatogram obtained with the test solution corresponds to that reference solution(a)
B)Melting PointB)More than 165°C
Clarity & Colour of SolutionThe solution is clear and colourless to faint yellow solutions overall
Loss on DryingNot more than 2.0 %
ChloridesNot more than 500 ppm
Heavy metalsNot more than 20 ppm
Residue on IgnitionNot more than 0.1 %
Loss on DryingNot more than 0.5 %
Related substance By HPLC
Thiamine Monophosphate :Not more than 0.5 %
Benzoic Acid:Not more than 1.0 %
 Unknown Ind.Impurity:Not more than 0.1 %
 Thiourea:Not more than 0.2 %
 Total Impurity:Not more than 2.0 %
Assay (On Dried Basis)Between 98.0 to 102.0 %
  
PACKING:25Kg Fiber Drum/HDPE Drum with double inner polythene bag

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