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Purification and quality control of the radiopharmaceutical 89SrCl2 produced in FBTR

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Abstract

Therapeutic radiopharmaceutical 89SrCl2 is used for bone pain palliation in metastatic bone cancer. No carrier added 89Sr is being produced using 89Y(n, p)89Sr reaction in FBTR, IGCAR, Kalpakkam. Standardization, demonstration of chemical processing of irradiated yttria inside hotcell and quality control of 89SrCl2 radiopharmaceutical have been described in this work in detail. Two stage extraction with 0.1M DtBuCH18C6/ 1-Octanol followed by two stage scrubbing and three stage back extraction yielded a pure fraction of 89Sr, which was free from other impurities produced during the irradiation. Detailed physicochemical and biological quality control of the final product have been standardised, demonstrated and meeting the recommendations according to the US, EU and International pharmacopeia.

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Abbreviations

DtBuCH18C6:

4,4’(5’) di-tert-butylcyclohexano-18-crown-6

%E:

% extraction in the organic phase

D:

distribution ratio

Vaq :

volume of aqueous phase

Vorg :

volume of organic phase

fn :

fraction of solute not extracted in nth step

SREX:

strontium extraction

TBP:

Tri-n- butyl phosphate

TRUEX:

TRans Uranium EXtraction

D2EHPA:

di-(2-ethylhexyl) phosphoric acid

LSC:

liquid scintillation counting

HPGe:

high purity germanium

HLLW:

high level liquid waste

ppm:

parts per million (mg/L)

Ci:

curie

Bq:

becquerel

nca:

no carrier added

CF:

carrier free

CA:

carrier added

LOD:

limit of detection

LOQ:

limit of quantification

FBTR:

Fast Breeder Test Reactor

IGCAR:

Indira Gandhi Centre for Atomic Research

MC&MFCG:

Materials Chemistry and Metal Fuel Cycle Group

BRIT:

Board of Radiation & Isotope Technology

DAE:

Department of Atomic Energy

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Acknowledgement

The authors gratefully acknowledge the assistance received from Shri E Mohan Raj, Shri V. Suresh Kumar, Mechanical team, electrical team of MC&MFCG, Dr K Anantha Sivan, former AD, MFCG, MC&MFCG for the commissioning of Biosafety Cabinet at MC&MFCG, Dr K. V. Suresh Kumar, Director, R.F.G. and his team for irradiation in FBTR, Shri P K Chaurasia and his team, IDEAS, MMG, for encapsulation of the pellets in the irradiation capsule, and Dr R Divakar and his team of RML for post irradiation subassembly processing. We acknowledge the support of ICP OES team, NRB, Kalpakkam and ICPOES, ICPMS teams of MC&MFCG for chemical analysis. The continuous support and encouragement from Dr S Vijayalakshmi, Head. ACSD, Dr V Jayaraman, Associate Director, Dr N Sivaraman, Director of MC&MFCG, are also gratefully acknowledged hereby. The authors gratefully acknowledge the constant support and encouragement received from former and present HoS, HoD, AD, Director of MC & MFCG and Director, IGCAR.

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Authors and Affiliations

  1. MC&MFCG, Indira Gandhi Centre for Atomic Research, A CI of Homi Bhabha National Institute (HBNI), Kalpakkam, Tamil Nadu, 603102, India

    Debasish Saha, J. Vithya, R. Karunakaran, T. Kalaiyarasu, S. Rajeswari, P. Manoravi, Manish Chand & R. Kumar

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  1. Debasish Saha
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  2. J. Vithya
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  3. R. Karunakaran
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Correspondence to Debasish Saha.

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Saha, D., Vithya, J., Karunakaran, R. et al. Purification and quality control of the radiopharmaceutical 89SrCl2 produced in FBTR. J Radioanal Nucl Chem 332, 33–46 (2023). https://doi.org/10.1007/s10967-022-08714-2

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