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FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

5

Thanks Scott,

We have extended the SLV to carry out recovery studies with biocytin. The recoveries confirm the affinity of IAC for biocytin. The data

from SLV is given below.

Placebo

Spike Levels

Recovery (%)

Day 1

Day 2

Day 3

Average

Child Formula Powder

Biotin 50%

99.18

99.66

101.00

100.95

99.39

99.72

99.98

Biotin 150%

99.40

98.89

99.28

98.05

99.97

96.65

98.71

Biocytin 50%

90.20

98.40

94.30

Biocytin 150%

90.1

90.5

90.30

Infant Elemental

Powder

Biotin 50%

99.42

99.94

100.44

98.90

99.91

99.14

99.63

Biotin 150%

94.91

94.38

95.28

95.33

94.47

94.47

94.81

Biocytin 50%

97.10

100.20

98.65

Biocytin 150%

92.4

90.6

91.50

Adult Nutritional RTF,

High Fat

Biotin 50%

97.98

98.56

98.17

97.58

99.21

97.85

98.23

Biotin 150%

95.41

95.25

95.11

94.61

97.35

94.66

95.40

Infant Formula RTF,

Milk Based

Biotin 50%

97.15

97.73

96.51

97.50

97.18

97.85

97.32

Biotin 150%

94.87

95.13

95.51

95.86

95.06

94.77

95.20

*Infant Formula RTF,

Milk Based

Biotin 50%

97.49

98.07

93.52

94.50

97.51

98.19

96.55

Sample

Spike Levels

Day 1

Day 2

Day 3

Average

**Adult Nutritional RTF

High Protein

Biotin 50%

103.00

103.50

103.98

105.21

103.42

103.01

103.69

Biotin 100%

96.25

96.95

97.65

97.04

97.24

95.24

96.73

Kind Regards

George

From:

Scott Christiansen

[ mailto:Scott.Christiansen@perrigo.com ]

Sent:

Wednesday, 8 March 2017 5:13 a.m.

To:

George Joseph

< George.Joseph@asurequality.com >

Subject:

Biotin / Biocytin

Hello George,

I read with interest the summary of the biotin MLT. The results for biotin were

outstanding

. I was interested to see that no biocytin was

detected in any of the samples. Did you perform any experiments which would confirm biocytin would be quantitatively trapped on the

immunoaffinity column / eluted from it under the method conditions? The open question would be whether the lysine side chain would

interfere with the process, i.e. are the negative findings in the samples from the inability to adhere to the column, or be eluted from it?

I trust we will see you next week.

Tx, /Scott

Scott Christiansen

| Senior Manager

Perrigo Nutritionals

| Quality Control

Direct: 802.528.8604 (x358604) | Perrigo Cell: 802.309.3047

scott.christiansen@perrigo.com www.perrigo.com

| Quality Affordable Healthcare Products