Reactorul Nuclear de Cercetare si Productie de Radioizotopi VVR-S Magurele

1
National Institute of CD for Physics and
Nuclear Engineering (IFIN-HH) Horia
Hulubei Gamma Spectrometry and Neutron
Activation Analysis used in Pharmaceutical
products quality control
2

• IFIN-HH

3
CPR DEPARTMENT RESEARCH -PRODUCTION
RADIOISOTOPES AND RADIOPHARMACEUTICAL PRODUCTS
CENTRE ANALYSIS LABORATORY
4
ANAYSIS LABORATORY

• Since 2001
• CERTIFICATE LABORATORY
• of National Commission for Nuclear Activities
  Control (CNCAN)

5
(No Transcript)
6
(No Transcript)
7
Domains of tests

• 1.Qualitative and Quantitative Physico-chemical
  Analysis
• Atomic Absorbtion Spectrofotometry
• UV-Vis Spectrofotometry
• Neutron Activation Analysis
• Gravimetrical and volumetrical methods
• pH determinations
• 2.Radionuclidic analysis Gamma spectrometry
• 3.Radiochemical analysis-radiocromatographyque
  method
• 4.Microbiological analysis (sterility
  pirogenity toxicity biodistribution
  determinations)
• 5.Activity measurements
• 6.Dosimetrycal measurements
• 7.Examination of Radioactive sources

8

• Gamma Spectrometry its using in our Laboratory
  for
• Radiopharmaceutical Quality Control
• Radionuclidic purity determination
• Activity measurement
• Radionuclides identification
• Radioactive contamination control
• Neutron Activation Analysis

9

• Gamma Spectrometry
• CANBERRA Equipment consist in
• HP Ge detector with preamplificator
• Tension source with (0-4000) V domain
• ACCUSPEC-A multi-channel analyzer
• PC with analysis program
• The detector was calibrated in energy ( 50-1500
  keV) domain, using a standards set.

10

• Radionuclidic purity determination
• For principales Radiopharmaceuticals producted in
  our Department
• Na131I solution used in thyroidian cancer
  radiotheraphy
• Gelatine capsules with Na131I used in thyroidian
  affections diagnosis
• 99Mo-99mTc ROMTEC Generator for diagnosis
• P RN is calculated as proportion between the
  activity of specific radionuclide and the sum of
  all determined radionuclides activities
• PRN for radiopharmaceutical products must be more
  99.9

11
(No Transcript)
12
(No Transcript)
13
(No Transcript)
14

• Neutron Activation Analysis is used in our
  Laboratory for
• To determine possible impurities from not
  radioactive raw materials
• To determine the content of microelements in new
  pharmaceutical products

         
15
(No Transcript)
16
Target for neutron activation
Closed by welding
  h 100 mm              
Lead ? 25 mm
Sample      
Target for neutron activation
height 100 mm
Aluminium capsule
Sample and standards
Lead
? 25 mm
17
(No Transcript)
18

• Big variations of concentrations from element to
  element (from ppm to ) and differences of
  content for each element on different segments of
  plant

19

• Conclusion
• Gamma Spectrometry and Neutron Activation
  Analysis are two very sensitive methods for
  pharmaceutical quality control