U.S. PHARMACOPEIA

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Witch Hazel
» Witch Hazel is a clear, colorless distillate prepared from recently cut and partially dried dormant twigs of Hamamelis virginiana Linné.
Prepare Witch Hazel as follows. Macerate a weighed amount of the twigs for about 24 hours in about twice their weight of water, then distill until not less than 800 mL and not more than 850 mL of clear, colorless distillate is obtained from each 1000 g of the twigs taken. Add 150 mL of Alcohol to each 850 mL of distillate, and mix thoroughly.
Packaging and storage— Preserve in tight containers, and avoid exposure to excessive heat.
Specific gravity 841: between 0.979 and 0.983.
pH 791: between 3.0 and 5.0.
Nonvolatile residue— Evaporate 100 mL to dryness in a tared dish on a hot plate at 60: the weight of the residue does not exceed 25 mg (0.025%).
Limit of tannins—
Mobile phase A— Adjust 1000 mL of water with phosphoric acid to a pH of 2.5 ± 0.1. Filter and degas.
Mobile phase B— Use filtered and degassed acetonitrile.
Standard solution— Dissolve an accurately weighed quantity of tannic acid in water to obtain a solution having a known concentration of about 0.03 mg of tannic acid per mL.
Test solution— Use Witch Hazel.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 280-nm detector and a 5.0-mm × 15-cm column that contains packing L1 and is programmed to provide variable mixtures of Mobile phase A and Mobile phase B. Initially, the system is held at a mixture consisting of 90% Mobile phase A and 10% Mobile phase B for 5.0 minutes. The proportion of Solvent B to Solvent A is increased linearly to 100% over the next 15 minutes. The flow rate is about 1 mL per minute.
Procedure— Separately inject equal volumes (about 25 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the responses for all peaks. If any peak corresponding to the retention time of tannic acid in the Standard solution is present in the chromatogram of the Test solution, its peak area is no more than that of the tannic acid in the Standard solution.
Alcohol content, Method I 611: between 14.0% and 15.0% of C2H5OH.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Maged H. Sharaf, Ph.D., Senior Scientist
Expert Committee : (DSB05) Dietary Supplements - Botanicals
USP29–NF24 Page 2267
Phone Number : 1-301-816-8318