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Vinpocetine Tablets

This document provides specifications for vinpocetine tablets, including: 1) Vinpocetine tablets contain no less than 90% and no more than 110% of the labeled amount of vinpocetine. 2) Dissolution testing requires no less than 75% of the labeled amount of vinpocetine to dissolve within 30 minutes in 0.1N hydrochloric acid. 3) The tablets must also pass tests for disintegration, weight variation, packaging and storage requirements, and newly added labeling requirements.

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32 views

Vinpocetine Tablets

This document provides specifications for vinpocetine tablets, including: 1) Vinpocetine tablets contain no less than 90% and no more than 110% of the labeled amount of vinpocetine. 2) Dissolution testing requires no less than 75% of the labeled amount of vinpocetine to dissolve within 30 minutes in 0.1N hydrochloric acid. 3) The tablets must also pass tests for disintegration, weight variation, packaging and storage requirements, and newly added labeling requirements.

Uploaded by

WH PANDW
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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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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