GABAPENTIN IP
TESTSSPECIFICATIONS
DescriptionA white or almost white ,crystalline powder
Identification
A)By IRA)IR spectrum of test preparation should be concordant with that standard
B)By HPLCB)The principal peak in the assay chromatogram obtained with the test solution corresponds to that reference solution
SolubilityFreely soluble in water and in alkaline and acidic solutions
pH (2% w/v)Between 6.5 to 8.0
Related substances By HPLC
Impurity A:Not more than 0.1 %
Impurity B:Not more than 0.06 %
 Impurity E:Not more than 0.1 %
 Any other Impurity:Not more than 0.1 %
 Total Impurities:Not more than 0.5 %
Heavy metalsNot more than 20 ppm
WaterNot more than 0.5 %
Sulphated AshNot more than 0.1 %
Assay (On Dried Basis)Between 98.0 to 102.0 % w/w
  
PACKING:25Kg Fiber Drum/HDPE Drum with double inner polythene bag

GABAPENTIN BP 
TESTSSPECIFICATIONS
AppearanceWhite or almost white ,crystaline powder
SolubilitySpringly soluble in water,Slightly soluble in ethanol(96 percent) ,Practically insoluble in methylene chloride.It dissolves in dilute acids and diute solutions of alkali hydroxides
Identification By IRIR spectrum of test preparation should be concordant with that standard.
Appearance of solutionThe solution is clear and colourless
pH (2% w/v)Between 6.5 to 7.5
Related substances By HPLC 
 Impurity A:Not more than 0.15 %
 Any other Impurity:Not more than 0.10 %
 Total Impurities:Not more than 0.5 %
Chlorides Not more than 100 ppm
WaterNot more than 0.3 %
Sulfated AshNot more than 0.1 %
Assay (On Dried Basis)Between 97.5 and 102.0 % w/w
  
PACKING:25Kg Fiber Drum/HDPE Drum with double inner polythene bag

GABAPENTIN USP 
TESTSSPECIFICATIONS
AppearanceWhite or almost white ,crystaline powder
Identification 
A)By IRA)IR spectrum of test preparation should be concordant with that standard
B)By HPLCB)The principal peak in the assay chromatogram obtained with the test solution corresponds to that reference solution
WaterNot more than 0.5 %
pH (2% w/v)Between 6.5 to 8.0
Organic impurities By HPLC 
 Impurity A:Not more than 0.1 %
 Impurity β-isomer:Not more than 0.06 %
 Impurity E:Not more than 0.1 %
 Any other Impurity:Not more than 0.1 %
 Total Impurities:Not more than 0.5 %
Residue on IgnitionNot more than 0.1 %
Assay (On Dried Basis)Between 98.0 and 102.0 % w/w
  
PACKING:25Kg Fiber Drum/HDPE Drum with double inner polythene bag

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