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Table 2 r-hFSH and r-hLH protein content and in vivo bioactivity of mixed solutions of follitropin alfa and lutropin alfa

From: Administration of follitropin alfa and lutropin alfa combined in a single injection: a feasibility assessment

   Protein content Bioactivity*
   Target
(mcg/mL)
Measured
(mcg/mL)
CV
(%)
Target
(IU/mL)
Measured
(IU/mL)
Ratio Group 1 (n = 15) r-hFSH 16.2 16.5 1.2 225 216
  r-hLH 3.0 3.4 1.7 75 77
Ratio Group 2 (n = 15) r-hFSH 16.2 17.4 0.9 225 221
  r-hLH 3.0 3.5 2.9 75 76
Ratio Group 3 (n = 15) r-hFSH 27.0 26.9 1.1 375 339
  r-hLH 3.0 3.5 1.1 75 73
Ratio Group 4 (n = 15) r-hFSH 43.2 45.4 0.3 600 568
  r-hLH 3.0 3.5 2.9 75 77
  1. CV, coefficient of variation; r-hFSH, recombinant human follicle-stimulating hormone; r-hLH, recombinant human luteinizing hormone.
  2. The target protein content was calculated using the following conversion factors: 150 IU r-hFSH corresponds with 10.8 mcg; 75 IU r-hLH corresponds with 3 mcg.
  3. *All bioactivity measurements fell within the 80 – 125% of target, as specified by the United States Pharmacopeia for product labelling [20].