Passiflora incarnata Extract

Please note, this OEL/ADE monograph also applies to alternate CAS RN 8057-62-3. Passiflora incarnata extract is extracted from passionflower (aerial parts, such as stem and leaves; it may also contain flowers and fruits) and has been used in homeopathic medicines. Passiflora incarnata extract is reputed to have antispasmodic and sedative properties and has been used as an ingredient of homeopathic medicines and herbal remedies, chiefly in the form of a liquid extract tincture. Passiflora incarnata extract has been used as a natural medicine for the treatment of insomnia, anxiety, stress, nervousness, irritability, and sedation. Moreover, Passiflora incarnata extract is widely used as antiasthmatic and analgesic. In addition, Passiflora incarnata extract affects menopause symptoms such as vasomotor symptoms, insomnia, and depression. Passiflora incarnata extract has also being reported as an anticonvulsant.

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.

Please note: Due to the complexity and amount of studies regarding this compound—a Natural Health Product—increased cost is charged.

Passiflora incarnata Extract

CAS Registry Number:
Trade names:
Effidose®, Florasun®, Nervosite®
Natural Health Product:
$1,399 USD


Why do you need this OEL Fastrac monograph?

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:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

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