Phytonadione Compounded Oral Suspension

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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1 DEFINITION

Phytonadione Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of phytonadione (C₃₁H₄₆O₂).

Prepare Phytonadione Compounded Oral Suspension 1 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

^a Phytonadione 10-mg/mL Injectable Emulsion, Hospira, Inc., Lake Forest, IL.

^b Simple Syrup, Humco, Inc., Texarkana, TX.

Open the ampule(s) of Phytonadione Injection Emulsion and withdraw the contents through a 5-µm filter needle. Remove the filter needle and transfer the Phytonadione Injection Emulsion into a calibrated container. Add sufficient Simple Syrup to bring to final volume. Mix well.

2 ASSAY

Procedure

Mobile phase: Methanol and water (95:5)

Standard solution: 0.04 mg/mL of USP Phytonadione RS in methanol

Sample solution: Transfer 1.0 mL of Oral Suspension into a 25-mL volumetric ask and add methanol to volume.

2.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 270 nm

Column: 4.6-mm × 10-cm; 2.6-µm packing L1

Temperatures

Autosampler: 4°

Column: 35°

Flow rate: 1.2 mL/min

Injection volume: 40 µL

2.2 System suitability

Sample: Standard solution

[Note—The retention time for phytonadione is about 11.6 min.]

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

2.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of phytonadione (C₃₁H₄₆O₂) in the portion of Oral Suspension taken:

Result = (r_U /r_S ) × (C_S /C_U) × 100

r_U = peak response of phytonadione from the Sample solution

r_S = peak response of phytonadione from the Standard solution

C_S = concentration of USP Phytonadione RS in the Standard solution (mg/mL)

C_U = nominal concentration of phytonadione in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 3.2–4.2

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistance containers. Store at controlled room temperature or in a refrigerator.

Beyond-Use Date: NMT 60 days after the date on which it was compounded when stored at controlled room temperature or NMT 90 days after the date on which it was compounded when stored in a refrigerator

Labeling: Label it to indicate that it is to be well-shaken before use, and to state the Beyond-Use Date.

USP Reference Standards 〈11〉

USP Phytonadione RS▲ (USP 1-Aug-2019)