Table 2.
Theoretical and actual FSH bioactivities for Bravelle®, Menopur®, and a mixture of Bravelle® and Menopur® when reconstituted in 0.9% saline and mixed in the same syringe.
| Hormone (FSH:LH)a | Theoretical bioactivity IU/mL (%) | Actual bioactivity IU/mL (% claim) | L-valueb |
| Bravelle® (75:0) | 75 (100%) | 76.58 (102.1%) | 0.072 |
| Menopur® (75:75) | 75 (100%) | 76.0 (101.3%) | 0.072 |
| Bravelle® + Menopur® | |||
| (150:75) | 150 (100%) | 156.86 (104.6%) | 0.072 |
| (300:75) | 300 (100%) | 308.69 (102.9%) | 0.072 |
| (300:225) | 300 (100%) | 306.58 (102.2%) | 0.072 |
a Ratio of FSH:LH bioactivity expressed in IUs
b L-value refers to the confidence limit obtained after combining two replicates. The USP mandated L-value = 0.18; the more stringent L-value of 0.08 is set by Ferring Pharmaceuticals Inc. to more precisely and consistently assess bioactivity.