Anise oil is the common name for the essential oil obtained from the dried ripe fruits of the plant Pimpinella anisum L, which belongs to the Apiaceae (Umbelliferae) botanical family. The material of interest for medicinal use is the fruit (the whole cremocarp), generally entire, having an odor reminiscent of anethole. A small fragment of the thin, rigid, slightly curved pedicel is frequently attached. This herbal substance is administered in liquid or, after crushing, in solid dosage forms. Pimpinella anisum L., fructus (aniseed) is characterized by a content of essential oil (anise oil) not lower than 20 mL per kg anhydrous fruit and its medicinal properties are mainly attributed to its content of essential oil. Other constituents include flavonol glycosides, phenolic acid, a phenolic glycoside, furocoumarins, (mainly bergapten), hydroxycoumarins, (mainly umbelliferone) and fixed oil and lipids, (mainly constituted of petroselinic acid). Twelve new and 5 known glycosides of phenylpropanoids, including 4 stereoisomers of anethole glycol 2’-O-beta-D-glucopyranoside and 4 stereoisomers of 1’-(4-hydroxyphenyl)propane-1’,2’-diol 2’-O-beta-glucopyranoside were extracted from the water-soluble portion of the methanolic extract of aniseed, together with anethole glycols and guaiacyl glycerol. The isolation and characterization of eight 2-Cmethyl- D-erythritol glycosides and of twelve phenylpropanoid glycosides from the watersoluble portion of aniseed have been carried out.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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