VARIABILITY IN THE IMMUNOREACTIVE AND BIOACTIVE FOLLICLE-STIMULATING-HORMONE CONTENT OF HUMAN URINARY MENOPAUSAL GONADOTROPIN PREPARATIONS

Citation
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
Citations number
29
Categorie Soggetti
Reproductive Biology
Journal title
ISSN journal
02681161
Volume
10
Issue
8
Year of publication
1995
Pages
1982 - 1986
Database
ISI
SICI code
0268-1161(1995)10:8<1982:VITIAB>2.0.ZU;2-0
Abstract
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.