Superiority
Identification
? I.R
? Colour test
? HPLC
Concordant with WS. On heating, Violet vapour evolves The retention time of the major peak in the …
Details
Identification
I.R
Colour test
HPLC
Concordant with WS. On heating, Violet vapour evolves The retention time of the major peak in the chromatogram of the sample solution corresponds to that observed in the chromatogram of the S.S.solution
Specific Rotation
(40% solution in water)
- 4.6°~ - 5.2°
Loss on drying
Not more than 0.5%
Residue on ignition
Not more than 0.1%
Free Aromatic Amine
Not more than 200 ppm
Free Iodine
No red colour
Free Iodide
Not more than 0.001%
Free Acid or Alkali
Acid not more than 5mg of HCL equivalent.
Alkali not more than 3mg of NaOHequivalent
Heavy metals
Not more than 0.001%
Related compounds byHPLC Total impurities
Not more than 0.25%
Assay (on dry basis)
98.0% ~ 101.0%