An implementation and using of a simple radiochemical purity assessment method of [99mTc]-etifenin


Authors: Jiří Štěpán
Authors‘ workplace: Klinika radiologie a nukleární medicíny, LF MU a FN Brno ;  Oddělení nukleární medicíny, Uherskohradištská nemocnice a. s., Uherské Hradiště
Published in: NuklMed 2017;6:62-66
Category: Original Article

Overview

Introduction:
Methods for a radiochemical purity (RCP) assessment of [99mTc]technetium-etifenin mentioned in a patient information leaflet (PIL) of ROTOP – EHIDA 20,0 mg kit are too tedious or less available. A currently valid method of the Czech Pharmacopoeia (Ph. Boh.) stated in its Supplement 2015 is more complicated too. A simplest (currently non-pharmacopoeial) method was stated in Ph. Boh. 2009 – Supplement 2011 and therefore this one has been verified and introduced to a common practice.

Subjects and methods:
A radiochromatography with scintillation detector NaI(Tl) attached to a multichannel analyzer MCA-1000G. A stationary phase was ITLC-SA (9 × 1 cm), a mobile phase was 0,9% NaCl, a path length was 7 cm. To find out a radioactivity distribution the strip was cut into 0,5cm ones. For RCP assessment the strip was cut only into three pieces in optimized points.

Results:
A retardation factor (RF) of [99mTc]-etifenin RF = 0,75 (compared to 0,5 stated in Ph. Boh. 2009 – Supplement 2011) was determined by a radioactivity distribution measurement. RF of [99mTc]technetium in colloidal form and [99mTc]pertechnetate ion were 0–0,1 and 0,9–1, respectively. For RCP assessment the strips were cut at points accordant with RF = 0,1 and RF = 0,9. Average RCP was calculated from 15 values and was (96,8 ± 1,1) %, average [99mTc]technetium in colloidal form and [99mTc]pertechnetate ion were (1,6 ± 0,4) % and (1,6 ± 0,9) %, respectively.

Conclusion:
The RCP assessment method according to Ph. Boh. 2009 – Supplement 2011 is applicable. A developed chromatogram can´t be cut into thirds as [99mTc]-etifenin isn´t in the middle of the chromatogram (as mentioned in Ph. Boh. 2009 – Supplement 2011) but around the point corresponding RF = 0,75. A cutting of the strip into three pieces at points accordant with RF = 0,1 and RF = 0,9 is convenient. The method is then reliable and RCP values were always satisfactory (minimum value 95,0 %).

Key words:
[99mTc]technetium-etifenin, [99mTc]technetium-EHIDA, N-(2,6-diethylacetanilido)iminodiacetic acid, [(2,6-diethylphenylcarbamoyl)methyl]iminodiacetic acid, radiochemical purity, [99mTc]technetium in colloidal form, [99mTc]pertechnetate ion


Sources

1. Ministerstvo zdravotnictví ČR. Český lékopis 2009 – Doplněk 2015: Praha, Grada, 2015, 968 p

2. Ministerstvo zdravotnictví ČR. Český lékopis 2009 – Doplněk 2011: Praha, Grada, 2011, 1552 p

3. INPHARMEX, spol. s r. o. Mikro-verze AISLP - ČR [CD-ROM]. 2017.1 pro MS Windows. Praha, INPHARMEX, spol. s r. o., 2017, 1 CD-ROM

4. Státní ústav pro kontrolu léčiv. Opatření obecné povahy 03-17, kterým stanovuje výši a podmínky úhrady individuálně připravovaných radiofarmak [online]. 2017. [cit. 2017-07-28]. Dostupné na World Wide Web: < http://www.sukl.cz/sukl/oop-03-17-stanoveni-vyse-a-podminek-uhrady-pripravovanych>

5. Zolle I ed. Technetium-99m Pharmaceuticals: Preparation and Quality Control in Nuclear Medicine. 1st edition, Berlin; Heidelberg; New York, Springer, 2007, 345 p

6. Rotop. Příbalová informace: informace pro uživatele, Rotop-EHIDA 20,0 mg kit pro radiofarmakum [online]. 2017 [cit. 2017-07-28]. Dostupné na World Wide Web: <http://www.sukl.cz/modules/medication/download.php?file=PI57051.pdf&type=pil&as=rotop-ehida-20-mg-kit-pro-radiofarmakum-pil>

7. IAEA (International Atomic Energy Agency). Technetium-99m Radiopharmaceuticals: Manufacture of Kits. Vienna, IAEA, 2008, 189 p, Technical reports series no. 466

8. Vyhláška č. 84 ze dne 11. března 2008 o správné lékárenské praxi, bližších podmínkách zacházení s léčivy v lékárnách, zdravotnických zařízeních a u dalších provozovatelů a zařízení vydávajících léčivé přípravky. In Sbírka zákonů České republiky. 2008, částka 25, s. 1104-1125

9. Ministerstvo zdravotnictví ČR. Český lékopis 2009 – Doplněk 2016: Praha, Grada, 2016, 1096 p

Labels
Nuclear medicine Radiodiagnostics Radiotherapy
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