Identification—
Dilute the Injection with acetone to obtain a solution containing 5 mg of nandrolone phenpropionate in each mL. Proceed as directed for
Identification test
C under
Nandrolone Phenpropionate, beginning with “Apply 10 µL of this solution.”
Limit of nandrolone—
Test preparation—
Transfer an accurately measured volume of Injection, equivalent to about 50 mg of nandrolone phenpropionate, to a 10-mL volumetric flask, dilute with acetone to volume, and mix.
Assay—
Isoniazid reagent—
Dissolve 500 mg of isoniazid in about 250 mL of methanol, add 0.63 mL of hydrochloric acid, dilute with methanol to 500.0 mL, and mix.
Standard preparation—
Transfer about 25 mg of
USP Nandrolone Phenpropionate RS, accurately weighed, to a 100-mL volumetric flask, dissolve in chloroform, dilute with chloroform to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with chloroform to volume, and mix.
Assay preparation—
Transfer an accurately measured volume of Injection, equivalent to about 50 mg of nandrolone phenpropionate, to a 200-mL volumetric flask, dilute with chloroform to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with chloroform to volume, and mix.
Procedure—
Transfer 5.0 mL each of the
Standard preparation, of the
Assay preparation, and of chloroform to provide the blank, to separate 10-mL volumetric flasks, dilute each flask with
Isoniazid reagent to volume, and mix. Allow the flasks to stand for 1 hour with occasional shaking. Concomitantly determine the absorbances of the solutions in 1-cm cells at the wavelength of maximum absorbance at about 380 nm, with a suitable spectrophotometer, against the blank. Calculate the quantity, in mg, of C
27H
34O
3 in each mL of the Injection taken by the formula:
(2C / V)(AU / AS),
in which
C is the concentration, in µg per mL, of
USP Nandrolone Phenpropionate RS in the
Standard preparation,
V is the volume, in mL, of Injection taken, and
AU and
AS are the absorbances of the solutions from the
Assay preparation and the
Standard preparation, respectively.
467
:
meets the requirements.