متفورمین

TEST

 STANDARD

Unit

Ref

Appearance

White or almost white crystals

-

BP 2020

Solubility

Freely soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in acetone and in methylene chloride

-

BP 2020

 IR spectra

Spectrum obtained with standard   Metformin Hydrochloride

 -

BP 2020

 Melting point

 222-226

 °C

BP 2020

 Appearance of solution

 Solution S is clear  and colourless

 -

BP 2020

 Impurity F

not more than the area of the corresponding peak in the chromatogram obtained with the  reference solution (0.05 per cent)

 %

BP 2020

 Related substances

impurity A: not more than the area of the corresponding peak in the

chromatogram obtained with  reference solution (a) (0.02 per cent)

 %

BP 2020

unspecified impurities: for each impurity, not more than 0.5 times the area of the principal peak in the

chromatogram obtained with  reference solution (b) (0.05 per cent)

Total impurities: NMT 0.2%

 Loss on drying

 Max 0.5

 %

BP 2020

 Assay (on the dried basis)

 98.5 - 101

 %

BP 2020

 Sulfated Ash 

 Max 0.1

 %

BP 2020

 Residual Solvent  (Methanol)

  Max 3000

 ppm

BP 2020