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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].