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National Institute of C&D for Physics and Nuclear Engineering (IFIN-HH) “Horia Hulubei” “Gamma Spectrometry and Neutron Activation Analysis used in Pharmaceutical products quality control”. IFIN-HH. CPR DEPARTMENT RESEARCH -PRODUCTION RADIOISOTOPES AND RADIOPHARMACEUTICAL PRODUCTS CENTRE

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National Institute of C&D for Physics and Nuclear Engineering (IFIN-HH) “Horia Hulubei”

“Gamma Spectrometry and Neutron Activation Analysis used in Pharmaceutical products quality control”


  • IFIN-HH Engineering (IFIN-HH) “Horia Hulubei”


CPR DEPARTMENT Engineering (IFIN-HH) “Horia Hulubei”

RESEARCH -PRODUCTION RADIOISOTOPES AND RADIOPHARMACEUTICAL PRODUCTS CENTRE

ANALYSIS LABORATORY


ANAYSIS LABORATORY Engineering (IFIN-HH) “Horia Hulubei”

Since 2001

  • CERTIFICATE LABORATORY

    of National Commission for Nuclear Activities Control (CNCAN)


Domains of tests Engineering (IFIN-HH) “Horia Hulubei”

  • 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


Gamma Spectrometry it’s using in our Laboratory for: Engineering (IFIN-HH) “Horia Hulubei”

  • Radiopharmaceutical Quality Control;

  • Radionuclidic purity determination;

  • Activity measurement;

  • Radionuclides identification;

  • Radioactive contamination control;

  • Neutron Activation Analysis


  • Gamma Spectrometry Engineering (IFIN-HH) “Horia Hulubei”

  • 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.


  • Radionuclidic purity determination Engineering (IFIN-HH) “Horia Hulubei”

    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%



Target for neutron activation Engineering (IFIN-HH) “Horia Hulubei”

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


Element Engineering (IFIN-HH) “Horia Hulubei”

Radioisotopes results from (n,) reaction

Half time

Gamma ray

(keV)

Scheme factor

Na

24Na

15.03 h

1368

100

Mg

27Mg

9.47 min.

1014

28

Al

28Al

2.31 min.

1778

100

Cl

38Cl

37.3 min.

1642

32.8

K

42K

12.36 h

1525

17.8

Ca

47Ca

3.4 d

159

70

Sc

46Sc

83.9 d

889

100

V

52V

3.75 min.

1434

100

Mn

56Mn

2.58 h

847

99

Fe

59Fe

44.6 d

1099

56

Co

60Co

5.27 y

1173

100

La

140La

40.3 h

1596

96


Element Engineering (IFIN-HH) “Horia Hulubei”

Unit of concentration 

Leaf

Stem

Root

Uncertainty

(%)

Na

ppm

150

90

6750

5

Mg

ppm

800

940

1370

25

Al

ppm

320

680

2420

25

Cl

ppm

1320

3490

2520

10

K

%

3.34

4.91

1.46

2

Ca

%

5.56

-

0,21

2

Sc

ppm

-

-

1

30

V

ppm

1

-

11

50

Mn

ppm

45

20

45

5

Fe

%

0.08

-

-

10

Co

ppm

0.5

1.5

2

10

La

ppm

0.2

-

0.6

15

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


  • Conclusion: Engineering (IFIN-HH) “Horia Hulubei”

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


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