Re: Sm-153

[Louis_Hagler@BERLEX.COM]

The process that is used to produce clinically useful amounts of Sm-153 is
known to generate trace levels of radionuclidic impurities that have been
identified as isotopes of europium.  Europium-154, with a half-life of 8.6
years, is the major contaminant and is the one responsible for virtually
all of the radiation due to impurities.  From a quality assurance
perspective, the specifications for Quadramet call for the product to
contain less than 0.0093% of Eu-154 at expiry; this is equivalent to 0.093
microcuries of Eu-154 per millicurie of Sm-153.  In fact, the actual
measured values range from 0.06 to 0.08 microcuries of Eu-154 per
millicurie of Sm-153.

The usual hold-for-decay program requires the licensee to hold short-lived
radionuclides for at least 10 half-lives.  A 20-day period would be
appropriate for Sm-153, with a half-life of nearly 2 days.  However,
because of its long half-life, it will be possible to detect, well beyond
20 days, the microcurie amounts of Eu-154 that remain in the vial after
administration of Quadramet.

This should not present a problem for facilities that administer Quadramet
in the United States.  Berlex/DuPont has an established mechanism for
facilities to return Quadramet vials following use.  Syncor, a major
radiopharmaceutical distributor, also has a program for handling the return
Quadramet vials and unit dose syringes that are dispensed by Syncor.

 To contact DuPont for technical information or for information about
return of the vials, please call 1-800-362-2668.

To contact Berlex for medical or patient-related information, please
contact the Professional Services Department at 1-888-237-5394 (option 4,
option 1).


************************************************************************
The RADSAFE Frequently Asked Questions list, archives and subscription
information can be accessed at http://www.ehs.uiuc.edu/~rad/radsafe.html