Arginine Hydrochloride Injection
»Arginine Hydrochloride Injection is a sterile solution of Arginine Hydrochloride in Water for Injection.It contains not less than 9.5percent and not more than 10.5percent of C6H14N4O2·HCl.It contains no antimicrobial agents.
NOTE—The chloride ion content of Arginine Hydrochloride Injection is approximately 475mEq per L.
Packaging and storage— Preserve in single-dose containers,preferably of Type IIglass.
Labeling— The label states the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,or where the label states that the Injection is not for direct injection but is to be diluted before use,the label alternatively may state the total osmolar concentration in mOsmol per mL.
Identification—
A: Transfer 1mLof the Injection to a 200-mLvolumetric flask,and dilute with water to volume.To 1mLof this dilution add 2mLof a solution of 0.02%8-hydroxyquinoline in 3Nsodium hydroxide,and add 1mLof 0.1%N-bromosuccinimide solution:an orange color is produced.
B: It meets the requirements of the tests forChloride á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.01USP Endotoxin Unit per mg of arginine hydrochloride.
pHá791ñ: between 5.0and 6.5.
Other requirements— It meets the requirements underInjections á1ñ.
Assay—
Color reagent— Dissolve 28.0g of potassium hydroxide and 2.0g of potassium sodium tartrate in 100mLof water.Cool,and add,in the order named,100mg of 2,4-dichloro-1-naphthol,180mLof alcohol,and 20.0mLof 0.475%sodium hypochlorite solution.Mix by swirling,and allow to stand at room temperature for 1hour before using.ThisColor reagentmay be stored in a glass-stoppered bottle,in a refrigerator,for 2months.
Standard preparation— Dissolve an accurately weighed quantity of USP Arginine Hydrochloride RSin water,and dilute quantitatively and stepwise with water to obtain a solution having a known concentration of about 40µg per mL.
Assay preparation— Pipet into a 100-mLvolumetric flask a volume of Injection,equivalent to 200mg of arginine hydrochloride,add water to volume,and mix.Pipet 5mLof this solution into a 250-mLvolumetric flask,add water to volume,and mix.
Procedure— Transfer 2.0-mLportions of theAssay preparationand theStandard preparation,respectively,to separate flasks,and treat each as follows.Add 2.0mLof potassium iodide solution (3in 1000),mix,and allow to stand for 15minutes.Add 6.0mLofColor reagent,mix,and allow to stand for 15minutes.Add 2.0mLof sodium hypochlorite solution (19in 10,000),mix,and allow to stand for 15minutes.Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 520nm,with a suitable spectrophotometer,using water as the blank.Calculate the quantity,in mg,of C6H14N4O2·HCl in each mLof the Injection taken by the formula:
5(C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Arginine Hydrochloride RSin theStandard preparation;Vis the volume,in mL,of Injection taken;and AUand ASare the absorbances of the solutions from theAssay preparationand theStandard preparation,respectively.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 176
Pharmacopeial Forum:Volume No.27(6)Page 3244
Phone Number:1-301-816-8389