M. Rodgers et al., VARIABILITY IN THE IMMUNOREACTIVE AND BIOACTIVE FOLLICLE-STIMULATING-HORMONE CONTENT OF HUMAN URINARY MENOPAUSAL GONADOTROPIN PREPARATIONS, Human reproduction, 10(8), 1995, pp. 1982-1986
The within- and between-batch variation in the immunoreactive and in-v
itro bioactive FSH content of Pergonal, Metrodin and Metrodin-HP was i
nvestigated. Three batches of Pergonal and Metrodin, consisting of thr
ee ampoules in each batch, and three batches of Metrodin-HP, consistin
g 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 urina
ry standard 70/45. The variability in the FSH content of the preparati
ons was evaluated within and between batches by analysis of variance.
Within-batch variability of B-FSH was not observed in Pergonal or Metr
odin-HP but was seen in two batches of Metrodin in which the potency v
aried 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 < 0.0
1). A similar pattern of variability was observed for B-FSH. For Metro
din, 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. Furth
ermore, the extensive within-batch B-FSH variation from two batches co
nfounded any meaningful comparison of between-batch variability, For M
etrodin-HP, there was no between-batch B-FSH variation (29.0 +/- 6.1 t
o 33.0 +/- 0.3 IU/ampoule) and the R-FSH content was also well control
led (41.2 +/- 0.5 to 46.9 +/- 1.1 IU/ampoule), The B:I(bioassay:immuno
assay) FSH ratios of Pergonal (0.9 +/- 0.1, n = 9), Metrodin (2.2 +/-
0.3, n = 9) and Metrodin-HP (0.7 +/- 0.04, n = 5) were all dissimilar
(P < 0.03). Within- and between-batch variations were observed to vary
ing degrees in three human urinary gonadotrophin preparations. The var
iations in B-FSH content between the preparations appeared more extens
ive than for R-FSH. Of the preparations studied, Metrodin-HP exhibited
the least variability.