Phytonadione Injectable Emulsion
(Monograph under this new title—to become official February 1,2005)
(Current monograph title is Phytonadione Injection)
»Phytonadione Injectable Emulsion is a sterile,aqueous dispersion of Phytonadione.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C31H46O2.It contains suitable solubilizing and/or dispersing agents.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass,protected from light.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 14.0USP Endotoxin Units per mg of phytonadione.
pHá791ñ: between 3.5and 7.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— [NOTE—Use low-actinic glassware throughout this assay,and otherwise protect the solutions from exposure to light.]
Mobile phase— Prepare a suitable degassed mixture of dehydrated alcohol and water (95:5).
Standard preparation— Dissolve an accurately weighed quantity of USP Phytonadione RSin Mobile phaseto obtain a solution having a known concentration of about 1mg per mL.Pipet 1mLof this solution into a 10-mLvolumetric flask,dilute with Mobile phaseto volume,and mix to obtain a Standard preparationhaving a known concentration of about 0.1mg per mL.
Assay preparation 1(containing 10mg or more of phytonadione per mL)— Pipet a volume of Injectable Emulsion,equivalent to 10mg of phytonadione,into a 10-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Pipet 1mLof this solution into a 10-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Assay preparation 2(containing less than 10mg of phytonadione per mL)— Pipet a volume of Injectable Emulsion,equivalent to 1mg of phytonadione,into a 10-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Chromatographic system(see Chromatography á621ñ)— The liquid chromatograph is equipped with a 254-nm detector and a 4-mm ×25-cm column that contains packing L1.The flow rate is about 0.7mLper minute.Chromatograph five replicate injections of the Standard preparation,and record the peak responses as directed for Procedure:the relative standard deviation is not more than 1.5%.
Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the appropriate Assay preparationinto the chromatograph,record the chromatograms,and measure the peak response for the major peak.Calculate the quantity,in mg,of C31H46O2in each mLof the Injectable Emulsion taken by the formula:
D(C/V)(rU/rS),
in which Dis 100if the Injectable Emulsion contains 10mg or more of phytonadione per mL,or 10if the Injectable Emulsion contains less than 10mg of phytonadione per mL;Cis the concentration,in mg per mL,of USP Phytonadione RSin the Standard preparation;Vis the volume,in mL,of Injectable Emulsion taken;and rUand rSare the peak responses of phytonadione obtained from the appropriate Assay preparationand the Standard preparation,respectively.
(Official February 1,2005)
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 1558
Pharmacopeial Forum:Volume No.28(6)Page 1853
Phone Number:1-301-816-8389