Phytonadione Injectable Emulsion

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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Phytonadione Injectable Emulsion is a sterile, aqueous dispersion of Phytonadione. It contains not less than 90.0 percent and not more than 110.0 percent 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 I glass, protected from light. USP Reference standards 〈11〉—

USP Phytonadione RS

Identication—The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

Bacterial Endotoxins Test 〈85〉 —It contains not more than 14.0 USP Endotoxin Units per mg of phytonadione.

pH 〈791〉: between 3.5 and 7.0.

Other requirements—It meets the requirements under Injections and Implanted Drug Products 〈1〉.

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 RS in Mobile phase to obtain a solution having a known concentration of about 1 mg per mL. Pipet 1 mL of this solution into a 10-mL volumetric flask, dilute with Mobile phase to volume, and mix to obtain a Standard preparation having a known concentration of about 0.1 mg per mL.

Assay preparation 1 (containing 10 mg or more of phytonadione per mL)—Pipet a volume of Injectable Emulsion, equivalent to 10 mg of phytonadione, into a 10-mL volumetric flask, dilute with Mobile phase to volume, and mix. Pipet 1 mL of this solution into a 10-mL volumetric flask, dilute with Mobile phase to volume, and mix.

Assay preparation 2 (containing less than 10 mg of phytonadione per mL)—Pipet a volume of Injectable Emulsion, equivalent to 1 mg of phytonadione, into a 10-mL volumetric flask, dilute with Mobile phase to volume, and mix.

Chromatographic system (see Chromatography 〈621〉)—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 0.7 mL per minute. Chromatograph ve 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 10 µL) of the Standard preparation and the appropriate Assay preparation into the chromatograph, record the chromatograms, and measure the peak response for the major peak. Calculate the quantity, in mg, of C₃₁H₄₆O₂ in each mL of the Injectable Emulsion taken by the formula:

D(C/V)(r_U /r_S )

in which D is 100 if the Injectable Emulsion contains 10 mg or more of phytonadione per mL, or 10 if the Injectable Emulsion contains less than 10 mg of phytonadione per mL; C is the concentration, in mg per mL, of USP Phytonadione RS in the Standard preparation; V is the volume, in mL, of Injectable Emulsion taken; and r_U and r_S are the peak responses of phytonadione obtained from the appropriate Assay preparation and the Standard preparation, respectively.