Sodium Fluoride ( F) Injection
01/2008:2100
18
European Pharmacopoeia 8.0
Thanita Saonam (Thailand)
Janis Rudzitis (Latvia)
PERC 2015, Ljubljana, Slovenia
The Contents of the Monograph
01/2008:2100
• Definition
• Production
• Characters
• Identification
• Tests
• Radioactivity
• Labelling
Product information
• Definition – description of the Product and the
Content of the Product
Containing fluorine-18 in the form of sodium fluoride
Content : fluorine-18 : 90% - 110% of the declared
F18 radioactivity
fluoride : maximum 4.52 mg per maximum
recommended dose in milliliters
• Production – describes how the Product is produced
Product information
• Characters – describes product appearance and
radionuclide Half-life and nature of radiation - General
chapter 5.7. Table of physical characteristics of
radionuclides.
Appearance : clear, colourless solution
Half-life : 109.77 min
Product identification
• Identification – shows information about the Product
identification Method and the desired results
- Gamma-ray spectrometry : 0.511 MeV
- Radionuclidic purity (It complies with test B for
radionuclidic purity)
- Radiochemical purity (see Tests)
Tests
• pH (2.2.3): 5.0 to 8.5
• Fluoride. Liquid chromatography (2.2.29)
– fluoride: not more than the area of the corresponding
peak in the chromatogram obtained with the reference
solution (4.52 mg/V)
• Sterility. It complies with the test for sterility prescribed
in the monograph on Radiopharmaceutical preparations
(0125)
• Bacterial endotoxins (2.6.14): less than 175/V IU/mL, V
being the maximum recommended dose in milliliters
Radionuclidic purity and Radiochemical purity
• Radionuclidic purity of the product – F-18: minimum 99,9 per cent of total
activity.
The preparation may be released for use before completion of the tests:
A. Gamma-ray spectrometry : 0.511 MeV
B. Half-life: 105 min to 115 min
• Radiochemical purity
[18F]fluoride. Liquid chromatography (2.2.29) as described in the test for
fluoride. If necessary, dilute the test solution with water R to obtain a
radioactivity concentration suitable for the radioactivity detector.
– [18F]fluoride: minimum 98.5 per cent of the total radioactivity.
Radioactivity and Labelling
• Determination of the radioactivity with calibrated instrument
• The label states the maximum recommended dose in milliliters
If Questions – We all know where look for the
answers!
Thank You!