Phytonadione Tablets
DEFINITION
Phytonadione Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of phytonadione (C31H46O2).
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.
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.
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
4-mm × 30-cm; packing L1
Flow rate:
1.5 mL/min
Injection size:
10 µL
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. ]
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of phytonadione (C31H46O2) in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak area from the Sample solution |
| rS | = | = peak area from the Standard solution |
| CS | = | = concentration of USP Phytonadione RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of phytonadione in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Disintegration 
701
701
Time:
30 min
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed, light-resistant containers.
• USP Reference Standards 11
11
USP Phytonadione RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Natalia Davydova
Scientific Liaison 1-301-816-8328 |
(DS2010) Monographs - Dietary Supplements |
| 701 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4319