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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.

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

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

  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.