TECHNESCAN SESTAMIBI kit for the preparation of technetium [99m Tc] sestamibi injection, Landauer Radiopharmaceuticals Pty Ltd, CON-959
Product name
TECHNESCAN SESTAMIBI kit for the preparation of technetium [99m Tc] sestamibi injection
Sponsor name
Landauer Radiopharmaceuticals Pty Ltd
ARTG
170503
Consent start
Consent no.
CON-959
Standard
The current British Pharmacopoeia (BP) monograph for Copper Tetramibi Tetrafluoroborate for Radiopharmaceutical Preparations
Non-compliance with standard
The product(s) do not meet the following BP monograph acceptance criteria copper
content limit of 10.04% - 11.04%, unspecified impurites limits of NMT 0.2%,
total impurites limit of NMT 0.5% and water content limit of NMT 0.5%.
Therapeutic product type
Prescription medicines