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Detection of the pyrogen in the radiopharmaceuticals using Limulus test and inhibitory factors in the gelation reaction

Abstract

To examine the sensitivities of the Limulus test and the inhibitory factors in radiopharmaceuticals, the following procedures were employed. Twenty commonly used radiopharmaceuticals were examined by Limulus Lysate (Pre-gel). In order to detect the inhibitory factors, several doses of endotoxin (E. coli) were added to the radiopharmaceuticals before the Limulus test was made and the results were compared with control results using saline solution of endotoxin. When the pH of the reaction solution lay out of a suitable range (6.0-7.5), the pH was adjusted by Tris-HCl buffer before the reaction. The sensitivity of the Limulus test control using Pre-gel was positive at a concentration of 10/sup -3/ ..mu..g/ml of endotoxin. The Limulus test was sensitive and without inhibitory reactions for sup(99m)TcO/sub 4/-, sup(99m)Tc-albumin, sup(99m)Tc-MAA, sup(99m)Tc-Sn-colloid, /sup 131/I-hippurate, Na/sup 131/I, Na/sub 2//sup 51/CrO/sub 4/, /sup 67/Ga-citrate and /sup 57/Co-bleomycin as they were supplied. /sup 111/In-DTPA, sup(99m)Tc-phytate, sup(99m)Tc-pyrophosphate, sup(99m)Tc-DTPA, /sup 131/I-PVP, /sup 59/FeCl/sub 3/, Na-phosphate (/sup 32/P), /sup 198/Au-colloid and /sup 75/Se-selenomethionine needed to have their pH adjusted to avoid inhibition. Benzyl alcohol in the radiopharmaceutical showed an inhibitory effect at a concentration greater than 1%. Commonly used /sup 169/Yb-DTPA which was evaluated by this test had a sensitivity of 2.5 x  More>>
Authors:
Murata, H; Iio, M; Yamada, H; Chiba, K; [1]  Kobayashi, M
  1. Tokyo Metropolitan Geriatric Medical Center (Japan)
Publication Date:
Aug 01, 1975
Product Type:
Journal Article
Reference Number:
AIX-07-262620; EDB-77-020351
Resource Relation:
Journal Name: Radioisotopes (Tokyo); (Japan); Journal Volume: 24:8
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; RADIOPHARMACEUTICALS; PYROGENS; QUALITY CONTROL; CHEMICAL ANALYSIS; CHEMICAL REACTIONS; ENDOTOXINS; INHIBITION; PH VALUE; SENSITIVITY; TOXICITY; ANTIGENS; CONTROL; DRUGS; LABELLED COMPOUNDS; RADIOACTIVE MATERIALS; TOXIC MATERIALS; TOXINS; 550601* - Medicine- Unsealed Radionuclides in Diagnostics
OSTI ID:
7137401
Country of Origin:
Japan
Language:
Japanese
Other Identifying Numbers:
Journal ID: CODEN: RAISA
Submitting Site:
INIS
Size:
Pages: 560-566
Announcement Date:
Oct 01, 1976

Citation Formats

Murata, H, Iio, M, Yamada, H, Chiba, K, and Kobayashi, M. Detection of the pyrogen in the radiopharmaceuticals using Limulus test and inhibitory factors in the gelation reaction. Japan: N. p., 1975. Web.
Murata, H, Iio, M, Yamada, H, Chiba, K, & Kobayashi, M. Detection of the pyrogen in the radiopharmaceuticals using Limulus test and inhibitory factors in the gelation reaction. Japan.
Murata, H, Iio, M, Yamada, H, Chiba, K, and Kobayashi, M. 1975. "Detection of the pyrogen in the radiopharmaceuticals using Limulus test and inhibitory factors in the gelation reaction." Japan.
@misc{etde_7137401,
title = {Detection of the pyrogen in the radiopharmaceuticals using Limulus test and inhibitory factors in the gelation reaction}
author = {Murata, H, Iio, M, Yamada, H, Chiba, K, and Kobayashi, M}
abstractNote = {To examine the sensitivities of the Limulus test and the inhibitory factors in radiopharmaceuticals, the following procedures were employed. Twenty commonly used radiopharmaceuticals were examined by Limulus Lysate (Pre-gel). In order to detect the inhibitory factors, several doses of endotoxin (E. coli) were added to the radiopharmaceuticals before the Limulus test was made and the results were compared with control results using saline solution of endotoxin. When the pH of the reaction solution lay out of a suitable range (6.0-7.5), the pH was adjusted by Tris-HCl buffer before the reaction. The sensitivity of the Limulus test control using Pre-gel was positive at a concentration of 10/sup -3/ ..mu..g/ml of endotoxin. The Limulus test was sensitive and without inhibitory reactions for sup(99m)TcO/sub 4/-, sup(99m)Tc-albumin, sup(99m)Tc-MAA, sup(99m)Tc-Sn-colloid, /sup 131/I-hippurate, Na/sup 131/I, Na/sub 2//sup 51/CrO/sub 4/, /sup 67/Ga-citrate and /sup 57/Co-bleomycin as they were supplied. /sup 111/In-DTPA, sup(99m)Tc-phytate, sup(99m)Tc-pyrophosphate, sup(99m)Tc-DTPA, /sup 131/I-PVP, /sup 59/FeCl/sub 3/, Na-phosphate (/sup 32/P), /sup 198/Au-colloid and /sup 75/Se-selenomethionine needed to have their pH adjusted to avoid inhibition. Benzyl alcohol in the radiopharmaceutical showed an inhibitory effect at a concentration greater than 1%. Commonly used /sup 169/Yb-DTPA which was evaluated by this test had a sensitivity of 2.5 x 10/sup -3/ ..mu..g/ml due to addition of a small amount of benzyl alcohol. /sup 131/I-BSP showed intense inhibition in gelation reaction. Contaminations of endotoxin were detected in sup(99m)Tc-albumin, sup(99m)Tc-Sn-colloid, /sup 131/I-hippurate, Na/sup 131/I, Na/sub 2//sup 51/CrO/sub 4/, /sup 198/Au-colloid, /sup 57/Co-bleomycin and /sup 75/Se-selenomethionine.}
journal = []
volume = {24:8}
journal type = {AC}
place = {Japan}
year = {1975}
month = {Aug}
}