DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of

Residual Solvents by GC

BACHEM, Inc.
Version 1.0

Validation Protocol P04-056

Module 3, Open Part

Page 1

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 2

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 3

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 4

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 5

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 6

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 7

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 8

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 9

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 10

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 11

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 12

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 13

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 14

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 15

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 16

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 17

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 18

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 19

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

BACHEM, Inc.
Version 1.0

Validation Final Report F04-056

Module 3, Open Part

Page 20

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 21

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 22

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 23

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 24

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 25

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 26

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 27

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 28

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 29

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 30

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 31

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 32

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 33

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 34

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 35

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 36

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 37

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 38

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 39

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 40

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 41

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 42

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 43

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 44

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 45

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 46

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 47

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 48

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 49

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 50

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 51

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 52

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 53

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 54

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 55

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 56

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 57

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 58

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 59

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 60

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 61

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 62

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 63

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 64

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 65

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 66

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 67

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 68

DMF Dossier HexGRF (1-44), Acetate

3.2.S.4.3 Document 4 - Validation of Method for Determination of
Residual Solvents by GC

Module 3, Open Part

BACHEM, Inc.
Version 1.0

Page 69