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Quality assurance of radiopharmaceuticals - specifications and test procedures

Technical Report:

Abstract

The authors report on a Radiopharmaceutical Quality Assurance Test Programme carried out by the Australian Radiation Laboratory in which radiopharmaceuticals used in nuclear medicine in Australia are tested for compliance with specifications. Where the radiopharmaceutical is the subject of a monograph in the British Pharmacopoeia or the European Pharmacopoeia, then the specifications given in the Pharmacopoeia are adopted. In other cases the specifications given have been adopted by this Laboratory and have no legal status. In some cases test procedures described have been taken from various Pharmacopoeias or methods published in the literature. In other cases test methods described have been developed at this Laboratory. It should be noted that, unless stated otherwise, specifications listed apply at all times up until product expire.
Publication Date:
Oct 01, 1990
Product Type:
Technical Report
Report Number:
ARL-TR-093(ed.2)
Reference Number:
SCA: 400702; PA: AIX-25:001870; EDB-94:014202; ERA-19:004696; NTS-94:014051; SN: 93001119672
Resource Relation:
Other Information: PBD: Oct 1990
Subject:
38 RADIATION CHEMISTRY, RADIOCHEMISTRY, AND NUCLEAR CHEMISTRY; RADIOPHARMACEUTICALS; PERFORMANCE TESTING; QUALITY ASSURANCE; BIOLOGICAL AVAILABILITY; IMPURITIES; LABELLED COMPOUNDS; RADIOCHEMISTRY; SPECIFICATIONS; SPECTROSCOPY; 400702; PROPERTIES OF RADIOACTIVE MATERIALS
OSTI ID:
10109504
Research Organizations:
Australian Radiation Lab., Melbourne, VIC (Australia)
Country of Origin:
Australia
Language:
English
Other Identifying Numbers:
Other: ON: DE94608555; TRN: AU9313483001870
Availability:
OSTI; NTIS (US Sales Only); INIS
Submitting Site:
INIS
Size:
155 p.
Announcement Date:
Jun 30, 2005

Technical Report:

Citation Formats

Baldas, J, Bonnyman, J, Colmanet, S F, Ivanov, Z, and Lauder, R A. Quality assurance of radiopharmaceuticals - specifications and test procedures. Australia: N. p., 1990. Web.
Baldas, J, Bonnyman, J, Colmanet, S F, Ivanov, Z, & Lauder, R A. Quality assurance of radiopharmaceuticals - specifications and test procedures. Australia.
Baldas, J, Bonnyman, J, Colmanet, S F, Ivanov, Z, and Lauder, R A. 1990. "Quality assurance of radiopharmaceuticals - specifications and test procedures." Australia.
@misc{etde_10109504,
title = {Quality assurance of radiopharmaceuticals - specifications and test procedures}
author = {Baldas, J, Bonnyman, J, Colmanet, S F, Ivanov, Z, and Lauder, R A}
abstractNote = {The authors report on a Radiopharmaceutical Quality Assurance Test Programme carried out by the Australian Radiation Laboratory in which radiopharmaceuticals used in nuclear medicine in Australia are tested for compliance with specifications. Where the radiopharmaceutical is the subject of a monograph in the British Pharmacopoeia or the European Pharmacopoeia, then the specifications given in the Pharmacopoeia are adopted. In other cases the specifications given have been adopted by this Laboratory and have no legal status. In some cases test procedures described have been taken from various Pharmacopoeias or methods published in the literature. In other cases test methods described have been developed at this Laboratory. It should be noted that, unless stated otherwise, specifications listed apply at all times up until product expire.}
place = {Australia}
year = {1990}
month = {Oct}
}