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Table 4 Theoretical and actual LH bioactivities for Menopur®, and a mixture of Bravelle® and Menopur® when reconstituted in 0.9% saline and mixed in the same syringe.

From: Mixed protocols: Multiple ratios of FSH and LH bioactivity using highly purified, human-derived FSH (BRAVELLE) and highly purified hMG (MENOPUR) are unaltered by mixing together in the same syringe

Hormone (FSH:LH)a

Theoretical bioactivity IU/mL (%)

Actual bioactivity IU/mL (% claim)

L-valueb

Menopur® (75:75)

75 (100%)

77.50 (103.3%)

0.061

Bravelle® + Menopur®

(150:75)

75 (100%)

78.38 (104.5%)

0.061

(300:75)

75 (100%)

78.63 (104.8%)

0.061

(300:225)

225 (100%)

233.48 (103.8%)

0.061

  1. a Ratio of FSH:LH bioactivity expressed in IUs
  2. 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.