Effect of batch size and lyophilization condition of dextran-70 radiopharmaceutical kit production for 99m-Technetium preparation

Name: Thidarat Kohud

Organization : Thailand Institute of Nuclear Technology (Public Organization). Radioisotope Center

Email : thidarat@tint.or.th

Name: Wanpen Rangsawai

Organization : Thailand Institute of Nuclear Technology (Public Organization). Radioisotope Center

Name: Sanguansak Hykunya

Organization : Thailand Institute of Nuclear Technology (Public Organization). Radioisotope Center

Name: Boon-Uma Jowanaridhi

Organization : Thailand Institute of Nuclear Technology (Public Organization). Radioisotope Center

Name: Siriwat Thida

Organization : Thailand Institute of Nuclear Technology (Public Organization). Radioisotope Center

Name: Krittika Somruedee

Organization : Thailand Institute of Nuclear Technology (Public Organization). Radioisotope Center

keyword: Technetium-99m

LCSH: Dextran

; Lymphoscintigraphy

LCSH: Radiolabeling

LCSH: Colloids -- Analysis

Abstract: Dextran-70 in colloid form was labeled with 99m-Technetium for lymphoscintigraphy. With the increasing demand for the dextran-70 colloid cold kit, production had to increase the batch size from 200 vials to 800 vials. In addition, the increase in batch size required changes in the lyophilization conditions. The change was made in the freezing step. For the older freezing condition, the shelf temperature was decreased to -70°C and then increased to -40°C before proceeding to the primary drying step. For the newer freezing condition, the shelf temperature was decreased to -60°C and held at -60°C for 4 hours. Both the older and newer conditions were investigated for particle size distribution, polydispersity index (PDI), and intensity by dynamic light scattering (DLS). Moreover, both conditions were analyzed for percent radiochemical purity (RCP). The particle size distribution, PDI, and intensity of the older condition were 171.6±16.7 nm, 0.152±0.018, and 15.3±0.7, respectively. On the other hand, the particle size distribution, PDI, and intensity of the newer condition were 186.2±2.2 nm, 0.11±0.017, and 17±1.5, respectively. The percent radiochemical purity of the older and newer conditions was 99.7±0.14% and 99.4±0.12%, respectively. The appearance of the new condition showed an elegant cake as seen in Figure 1. Therefore, the dextran-70 colloid cold kit could be produced in a batch size of 800 vials using the new freeze-drying condition

King Mongkut's University of Technology North Bangkok. Central Library

Address: BANGKOK

Email: library@kmutnb.ac.th

Created: 2025

Modified: 2025-10-24

Issued: 2025-10-24

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BibliograpyCitation : In The Chemical Society of Thailand under the Patronage of Professor Dr. Her Royal Highness Princess Chulabhorn Krom Phra Srisavangavadhana and Suranaree University of Technology. Institute of Science. School of Chemistry. Pure and Applied Chemistry International Conference 2025 (PACCON 2025) (pp.384-388). Bangkok : The Chemical Society of Thailand under the Patronage of Professor Dr. Her Royal Highness Princess Chulabhorn Krom Phra Srisavangavadhana in association with the School of Chemistry, Institute of Science, Suranaree University of Technology, 2025

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