Phytonadione Tablets

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 Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of phytonadione (C₃₁H₄₆O₂).

2 IDENTIFICATION

A. Ultraviolet Absorption

Standard solution: 0.01 mg/mL of USP Phytonadione RS in dehydrated alcohol

Sample solution: A portion of finely powdered Tablets, equivalent to 0.01 mg/mL of phytonadione in dehydrated alcohol. Shake vigorously, and filter. Use the filtrate.

Acceptance criteria: The UV absorption spectrum of the Sample solution exhibits maxima and minima at the same wavelengths as that of the Standard solution concomitantly measured.

B. HPLC Identification Test

Analysis: Proceed as directed in the Assay.

Acceptance criteria: The retention time of the major peak of the Sample solution corresponds to that of the Standard solution.

3 ASSAY

Procedure

[Note—Use low-actinic glassware throughout the Assay, and otherwise protect the solutions from light.]

Mobile phase: Dehydrated alcohol and water (95:5)

Standard solution: 0.10 mg/mL of USP Phytonadione RS in dehydrated alcohol

Sample solution: 0.1 mg/mL of phytodione in dehydrated alcohol prepared as follows. Mix a portion of finely powdered Tablets (NLT 20) with dehydrated alcohol to obtain a nominal concentraion of 0.4 mg/mL of phytonadione. Shake by mechanical means for 15 min, dilute with dehydrated alcohol to 0.10 mg/mL, and filter.

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4-mm × 30-cm; packing L1

Flow rate: 1.5 mL/min

Injection size: 10 µL

3.2 System suitability

Sample: Standard solution (three replicate injections)

Suitability requirements

Column efficiency: NLT 915 theoretical plates, determined from the analyte peak

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

[Note—Z- and E-isomers coelute in this chromatographic system.]

3.3 Analysis

Samples: Standard solution and Sample solution

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

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

r_U = peak area from the Sample solution

r_S = peak area 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%

4 PERFORMANCE TESTS

Disintegration 〈701〉

Time: 30 min

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed, light-resistant containers.

USP Reference Standards 〈11〉

USP Phytonadione RS