» Lemon Tincture is prepared from lemon peel, which is the outer yellow rind of the fresh, ripe fruit of Citrus x Limon Osbeck (Fam. Rutaceae).
Prepare peel as directed for Process M in Tinctures under Pharmaceutical Dosage Forms 1151. Macerate 500 g of the lemon peel in 900 mL of alcohol in a closed container, and store in a warm place. Agitate the container frequently for 3 days or until the soluble matter is dissolved. Transfer the mixture to a filter, using talc as the filtering medium, and when most of the liquid has drained away, wash the residue on the filter with a sufficient amount of alcohol, and combine the filtrates so that the preparation is brought to a final volume of 1000 mL.
Packaging and storage Preserve Lemon Tincture in tight, light-resistant containers, and avoid exposure to direct sunlight and to excessive heat. Store at controlled room temperature.
Labeling The label states the Latin binomial and, following the official name, the part of the plant source from which the article was derived.
Heavy metals, Method II 231: not more than 0.004%.
Alcohol content, Method I 611: between 62% and 72% of the labeled amount of C2H5OH is found.
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USP32NF27 Page 1267Pharmacopeial Forum: Volume No. 28(5) Page 1464