Powder Tranexamic Acid Ip

Sr. No.TestSpecificationResults
1DescriptionA white or almost white crystalline powderWhite crystalline powder
2SolubilityFreely soluble in water and in Glacial Acetic Acid and practically insoluble in Acetone and in alcohol (95%)Complies
3Identification by FTIRIR spectrum of sample should be concordant with IR spectrum of tranexamic acid IP reference standard or IP reference spectrumComplies
4pH of the solution (5%w/v solution)Between 7.0 and 8.07.09
5ChloridesNot more than 140 ppmComplies
6Sulphated Ash (%w/w)Not more than 0.1%0.05%
7Heavy metalsNot more than 10 ppmComplies
8Loss on drying at 105C for 2 hours (%w/w)Not more than 0.5%0.30%
9Related substances by HPLC (%w/w)
a)Impurity A
b)Impurity B
c)Any other Impurity
d)Total Impurity other than Impurity A&B
Not more than 0.1%
Not more than 0.2%
Not more than 0.1%
Not more than 0.2%