Changes to the European Pharmacopoeia Essential Oils regarding Optical Rotation Measurements / Polarimeter Measurements
In April 2022 there is a change coming to the European Pharmacopoeia regarding the measurement of essential oils such as
Sweet Orange Oil. The revised monograph requires that samples now need to be measured in a 0.1 dm (10cm) length cell instead of the standard 100mm polarimeter cell.
Example of essential oil that is required to be tested in a 0.1 dm (10cm) length cell.
Measuring Sweet Orange Oil
Aurantii dulcis aetheroleum
Relative Density (2.2.5) : 0.842 to 0.850.
Refractive Index (2.2.6) : 1.470 to 1.476.
Optical Rotation (2.2.7) : +9.4° to +9.9°(measured in a 0.1 dm tube).
The Solution to meeting new European Pharmacopoeia requirements
Compliance with the new European Pharmacopeia requirements can be achieved with the purchase of a Rudolph .1dm/10mm length Polarimeter cell for use with Rudolph’s TempTrol® heating and cooling system. These cells are being made available by Rudolph throughout the world.
Regardless of origin, essential oils in products made or destined for the European Market will need to comply with this new requirement beginning in April of 2022.
Excerpt from the European Pharmacopoeia for Sweet Orange Oil.
Essential Oils in the European Pharmacopoeia: anise, bitter fennel, caraway, cassia, cinnamon bark, citronella, clove, coriander, eucalyptus, juniper, lavender, lemon, matricaria, neroli, peppermint, pine needle, pumilio pine, rosemary, thyme, turpentine, dementholized mint, nutmeg, sweet orange, cinnamon leaf, clary sage, mandarin, star anise, and tea tree).
Rudolph Research Analytical is available to assist you in remaining in compliance of the United States FDA, US 21CFR Part 11, the European Pharmacopoeia and other regulatory agencies around the world.
Now may be the time to upgrade to the latest generation of 21 CFR Part 11 software with a new Rudolph Polarimeter.
Contact us to see our current line up of instruments;
Phone: (973) 584-1558