Aluminium content of water for injection used with recombinant human erythropoietin.

ABSTRACT

Human recombinant erythropoietin is of proven value in the treatment of the anaemia of renal failure. The aluminium content of 36 ampoules of water for injection supplied for use with recombinant erythropoietin has been measured and ranged from 24 to 450 micrograms/l, with a median of 251 micrograms/l. In three samples, which may have been contaminated on opening, the range was from 1770 to 6160 micrograms/l. In Water for Injection BP, values ranged from 66 to 140 micrograms/l with a median of 99 micrograms/l. Reconstituted erythropoietin did not contain any more aluminium than could be accounted for by the water. Ampoules of a second brand of erythropoietin, supplied already in solution, contained from 506 to 837 micrograms/l aluminium (median 682 micrograms/l). In view of the lifelong duration of erythropoietin therapy clinicians and pharmaceutical companies should be aware of this potential problem. Although the amount of aluminium delivered with each injection is usually less than 4 micrograms, it is suggested that active steps are taken to establish a British Pharmacopoeia limit on the aluminium content of injections.