GUAIPHENESIN IP
TESTSSPECIFICATIONS
DescriptionA white or almost white ,crystalline powder,odourless or with a slight characteristic odour
Identification
A)By IRA)IR spectrum of test preparation should be concordant with that standard
B)By HPLCB)The principal peak in the chromatogram obtained with the test solution corresponds to that reference solution(a)
C)Melting PointC)Between 79°C to 83°C
Appearance of solution (2% w/v)Solution is clear and colourless
pH (1% w/v)Between 5.0 to 7.0
Related substances By HPLC
Impurity A:Not more than 0.1 %
Impurity B:Not more than 1.0 %
 Any other Impurity:Not more than 0.5 %
 Total Impurities(Excluding Impurity B):Not more than 1.0 %
Heavy metalsNot more than 25ppm
Chlorides and monochlorohydrinsNot more than 250ppm
GuaiacolComply as per Pharmacopoeia
Sulphated AshNot more than 0.1 %
Loss on DryingNot more than 0.5 %
Assay (On Dried Basis)Between 98.0 to 101.5 % w/w
  
PACKING:25Kg Fiber Drum/HDPE Drum with double inner polythene bag

GUAIFENESIN BP 
TESTSSPECIFICATIONS
AppearanceWhite or almost white ,crystaline powder
SolubilitySpringly soluble in water,soluble in ethanol(96 percent)
Identification 
A)Melting PointA)Between 79°C to 83°C
B)By IRB)IR spectrum of test preparation should be concordant with that standard
C)By TLCC)The principal spot in the chromatogram obtained with the test solution is similar position of reference solution
Appearance of solutionSolution S is clear and colourless
Acidity or alkalinityNot more than 0.1mL require 0.01M Sodium hydroxide to color change and 0.01M HCL
Related substances By HPLC 
 Impurity A:Not more than 0.1 %
 Impurity B:Not more than 0.5 %
 Impurity C:Not more than 0.1 %
 Impurity D:Not more than 0.1 %
 Any other Impurity:Not more than 0.05 %
 Total Impurities(Excluding Impurity B):Not more than 0.7 %
Chlorides and monochlorohydrinsNot more than 250ppm
Loss on DryingNot more than 0.5 %
Sulfated AshNot 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

GUAIFENESIN 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 UVMeets the requirments
Loss on DryingNot more than 0.5 %
Organic Impurities By HPLC 
 Guaiacol:Not more than 0.03 %
 Impurity β-isomer:Not more than 1.5 %
 Any other Impurity:Not more than 0.5 %
 Total Impurities(Excluding Impurity B and guaiacol):Not more than 1.0 %
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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