Variability in the immunoreactive and bioactive follicle stimulating hormone content of human urinary menopausal gonadotrophin preparations.
The within- and between-batch variation in the immunoreactive and in-vitro bioactive FSH content of Pergonal, Metrodin and Metrodin-HP was investigated. Three batches of Pergonal and Metrodin, consisting of three ampoules in each batch, and three batches of Metrodin-HP, consisting of between one and three ampoules per batch, were selected at random. The follicle stimulating hormone (FSH) content of Pergonal, Metrodin and Metrodin-HP was determined by radioimmunoassay (R-FSH) and the in-vitro rat Sertoli cell bioassay (B-FSH) using the international urinary standard 70/45. The variability in the FSH content of the preparations was evaluated within and between batches by analysis of variance. Within-batch variability of B-FSH was not observed in Pergonal or Metrodin-HP but was seen in two batches of Metrodin in which the potency varied by up to 2.4 fold (P = 0.03). The between-batch R-FSH potencies of Pergonal (P1-P3) varied, with P2 (59.8 +/- 0.6) and P3 (61.7 +/- 0.9) being higher than P1 (47.1 +/- 1.5 mean +/- SEM IU/ampoule, P < 0.01). A similar pattern of variability was observed for B-FSH. For Metrodin, each of the batch R-FSH potencies was dissimilar (P < 0.02), with estimates ranging from 34.9 +/- 1.2 to 64.3 +/- 1.8 IU/ampoule. Furthermore, the extensive within-batch B-FSH variation from two batches confounded any meaningful comparison of between-batch variability. For Metrodin-HP, there was no between-batch B-FSH variation (29.0 +/- 6.1 to 33.0 +/- 0.3 IU/ampoule) and the R-FSH content was also well controlled (41.2 +/- 0.5 to 46.9 +/- 1.1 IU/ampoule).(ABSTRACT TRUNCATED AT 250 WORDS)
Rodgers
M
M
Department of Clinical Biochemistry, Hope Hospital, Salford, UK.
McLoughlin
J D
JD
Lambert
A
A
Robertson
W R
WR
Mitchell
R
R
D000704:Analysis of Variance; D000818:Animals; D001681:Biological Assay; D002478:Cells, Cultured; D005640:Follicle Stimulating Hormone / Q000302:isolation & purification* / Q000652:urine*; D006801:Humans; D008297:Male; D008596:Menotropins / Q000302:isolation & purification* / Q000652:urine; D011863:Radioimmunoassay; D011897:Random Allocation; D051381:Rats; D017207:Rats, Sprague-Dawley; D015203:Reproducibility of Results; D012708:Sertoli Cells / Q000187:drug effects
D008596:Menotropins; D005640:Follicle Stimulating Hormone