Limit of nandrolone
Test preparation
Transfer an accurately measured volume of Injection,equivalent to about 50mg of nandrolone phenpropionate,to a 10-mLvolumetric flask,dilute with acetone to volume,and mix.
Assay
Isoniazid reagent
Dissolve 500mg of isoniazid in about 250mLof methanol,add 0.63mLof hydrochloric acid,dilute with methanol to 500.0mL,and mix.
Standard preparation
Transfer about 25mg of
USP Nandrolone Phenpropionate RS,accurately weighed,to a 100-mLvolumetric flask,dissolve in chloroform,dilute with chloroform to volume,and mix.Transfer 5.0mLof this solution to a 50-mLvolumetric flask,dilute with chloroform to volume,and mix.
Assay preparation
Transfer an accurately measured volume of Injection,equivalent to about 50mg of nandrolone phenpropionate,to a 200-mLvolumetric flask,dilute with chloroform to volume,and mix.Transfer 5.0mLof this solution to a 50-mLvolumetric flask,dilute with chloroform to volume,and mix.
Procedure
Transfer 5.0mLeach of the
Standard preparation,of the
Assay preparation,and of chloroform to provide the blank,to separate 10-mLvolumetric flasks,dilute each flask with
Isoniazid reagentto volume,and mix.Allow the flasks to stand for 1hour with occasional shaking.Concomitantly determine the absorbances of the solutions in 1-cm cells at the wavelength of maximum absorbance at about 380nm,with a suitable spectrophotometer,against the blank.Calculate the quantity,in mg,of C
27H
34O
3in each mLof the Injection taken by the formula:
(2C/V)(AU/AS),
in which
Cis the concentration,in µg per mL,of
USP Nandrolone Phenpropionate RSin the
Standard preparation,
Vis the volume,in mL,of Injection taken,and
AUand
ASare the absorbances of the solutions from the
Assay preparationand the
Standard preparation,respectively.