Printed on: Sun Aug 08 2021, 04:11:01 AM Official Status: Currently Official on 08-Aug-2021 DocId: 1_GUID-531C9417-EDC8-46B9-B411-90F3FAB00B9C_3_en-US

(EST)
Printed by: Le Tran Official Date: Official as of 01-Aug-2021 Document Type: DIETARY SUPPLEMENTS @2021 USPC
1

CU = nominal concentration of vinpocetine in the

Vinpocetine Tablets Sample solution (mg/mL)
DEFINITION
Acceptance criteria: 90.0%–110.0%
Vinpocetine Tablets contain NLT 90.0% and NMT 110.0% of
the labeled amount of vinpocetine (C22H26N2O2). PERFORMANCE TESTS
• DISINTEGRATION AND DISSOLUTION á2040ñ, Dissolution:
IDENTIFICATION Meet the requirements
• A. SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Medium: 0.1 N hydrochloric acid; 900 mL
Ultraviolet-Visible Spectroscopy: 197U Apparatus 1: 100 rpm
Medium: Alcohol Time: 30 min
Standard solution: 15 µg/mL of USP Vinpocetine RS in Sample solution: Withdraw a portion of the solution under
Medium test, pass through a suitable filter, and use the pooled
Sample solution: Equivalent to 15 µg/mL of vinpocetine sample as the test specimen.
from finely powdered Tablets in Medium Standard solution: Dissolve a suitable amount of USP
Acceptance criteria: The spectra of the Sample solution and Vinpocetine RS in Medium to obtain a concentration similar
Standard solution exhibit maxima and minima at the same to that of the Sample solution.
wavelengths. Instrumental conditions
• B. HPLC: The retention time of the major peak of the (See Ultraviolet-Visible Spectroscopy á857ñ.)
Sample solution corresponds to that of the Standard Mode: UV
solution, as obtained in Strength. Analytical wavelength: 268 nm
STRENGTH Blank: Medium
• PROCEDURE Analysis

al
Solution A: 15.4 g/L of ammonium acetate in water Samples: Sample solution and Standard solution
Mobile phase: Acetonitrile and Solution A (55:45) Calculate the percentage of the labeled amount of
Standard solution: 0.2 mg/mL of USP Vinpocetine RS in vinpocetine (C22H26N2O2) dissolved:
Mobile phase
Sample solution: Dissolve a portion from NLT 20 finely
ci Result = (AU/AS) × [CS × (V/L)] × 100
powdered Tablets in acetonitrile by shaking thoroughly and
sonicating for 5 min. Allow the solution to cool to room AU = absorbance of vinpocetine from the Sample
temperature, dilute with acetonitrile to get a solution solution
nominally equivalent to 0.2 mg/mL of vinpocetine, and AS = absorbance of vinpocetine from the Standard
filter. solution
CS = concentration of USP Vinpocetine RS in the
ffi
Chromatographic system
(See Chromatography á621ñ, System Suitability.) Standard solution (mg/mL)
Mode: LC V = volume of Medium, 900 mL
Detector: UV 280 nm L = label claim of vinpocetine (mg/Tablet)
Column: 4.6-mm × 25-cm; 5-µm packing L1
Flow rate: 1.0 mL/min Tolerances: NLT 75% of the labeled amount of
vinpocetine (C22H26N2O2) is dissolved.
O

Injection volume: 15 µL
System suitability • WEIGHT VARIATION á2091ñ: Meet the requirements
Sample: Standard solution ADDITIONAL REQUIREMENTS
Suitability requirements • PACKAGING AND STORAGE: Preserve in tight, light-resistant
Relative standard deviation: NMT 2.0% containers.
Analysis
Samples: Standard solution and Sample solution
Add the following:
Calculate the percentage of the labeled amount of
vinpocetine (C22H26N2O2) in the portion of Tablets taken: ▲
• LABELING: Label to include the following statement: "Do
not use if you are pregnant, planning to become pregnant,
Result = (rU/rS) × (CS/CU) × 100 or breastfeeding."▲ (USP 1-Aug-2021)
• USP REFERENCE STANDARDS á11ñ
rU = peak response from the Sample solution USP Vinpocetine RS
rS = peak response from the Standard solution
CS = concentration of USP Vinpocetine RS in the
Standard solution (mg/mL)

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