Nandrolone Phenpropionate Injection
» Nandrolone Phenpropionate Injection is a sterile solution of Nandrolone Phenpropionate in a suitable oil. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of nandrolone phenpropionate (C27H34O3).
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, protected from light.
USP Reference standards 11
USP Nandrolone RS
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
Standard preparation— Prepare as directed in the test for Limit of nandrolone under Nandrolone Decanoate Injection.
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.
Procedure— Proceed as directed for Procedure in the test for Limit of nandrolone under Nandrolone Decanoate Injection.
Other requirements— It meets the requirements under Injections 1.
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 C27H34O3 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.
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Topic/Question Contact Expert Committee
Monograph Mary S. Waddell
Scientific Liaison
1-301-816-8124
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 3992