[ 11 C]Mes-IMPY FOR INJECTION: CERTIFICATES OF ANALYSIS

Transcription

1 Table of Contents COA # Name Page Ware 1 COA of analytical column 3 2 COA of semi-prep column 4 3 COA of Millex GV 4 mm vent filter 5 4 COA of MiIlex MP 25 mm Sterile Filter 6 5 Sterile empty vial 7-9 Gas 6 COA of hydrogen 10 7 COA of helium 11 8 COA of 1 % oxygen in nitrogen 12 9 COA of nitrogen, Ultra High Purity 13 Solvent 10 COA of ethanol, USP COA of acetonitrile, HPLC grade COA methanol, HPLC grade COA of water, HPLC grade COA of DMSO 18 Reagents 15 Iodine, sublimed Acetonitrile, anhydrous tert-butylimino-tris(dimethylamino) 21 phosphorane 18 COA of Mes-IMPY COA of des-methyl Mes-IMPY COA of sodium bicarbonate COA of saline COA of phosphoric acid COA of polysorbate COA of dehydrated alcohol Page 1 of 42

2 Page 2 of 42

3 Page 3 of 42

4 Page 4 of 42

5 Page 5 of 42

6 Page 6 of 42

7 Page 7 of 42

8 Page 8 of 42

9 Page 9 of 42

10 Page 10 of 42

11 Page 11 of 42

12 Page 12 of 42

13 Page 13 of 42

14 Page 14 of 42

15 Page 15 of 42

16 Page 16 of 42

17 Page 17 of 42

18 Page 18 of 42

19 Page 19 of 42

20 Page 20 of 42

21 Certificate of Analysis for Mes-IMPY Product Name Mes-IMPY Product Number NA Product Brand Home-made CAS Number NA Molecular Formula C16H17N3S Molecular Weight TEST LOT RESULT Appearance (color) Off-white Appearance (form) Solid Assay (LC Area % at 254 nm) 98.8 Density D20/4 NA Refractive Index N20/D NA NMR Spectrum 1H Corresponds Date of QC-Release 10/August/2006 Page 21 of 42

22 Page 22 of 42

23 Page 23 of 42

24 Page 24 of 42

25 Page 25 of 42

26 Certificate of Analysis for methyl 3-(2-(4-(dimethylamino)phenyl)imidazo[1,2-a]pyridin- 6-ylthio)propanoate Product Name methyl 3-(2-(4-(dimethylamino)phenyl)imidazo[1,2- a]pyridin-6-ylthio)propanoate Product Number NA Product Brand Home-made CAS Number NA Molecular Formula C19H21N3O2S Molecular Weight TEST LOT RESULT Appearance (color) Off-white Appearance (form) Solid Assay (LC Area % at 254 nm) 96.1 Density D20/4 NA Refractive Index N20/D NA NMR Spectrum 1H Corresponds Date of QC-Release 10/August/2006 Page 26 of 42

27 Page 27 of 42

28 Page 28 of 42

29 Page 29 of 42

30 Page 30 of 42

31 Page 31 of 42

32 Page 32 of 42

33 Page 33 of 42

34 Page 34 of 42

35 Page 35 of 42

36 Polysorbate 80, N.F. Multi-Compendial CRILLET 4 HP TM CRILLET 4 HP (polyoxyethylene (20) sorbitan monooleate) Product No Lot No. C26619 Release Date 07/05/2006 GMP Manufactured Product Vegetable Based This product utilizes ingredients of non-animal origin and non-peanut origin. Meets N.F. Requirements Acid Value 2.2 max. 1.2 Heavy Metals (as Pb) % max. < % Hydroxyl Value Identification A Passes Test Passes Test Identification B Passes Test Passes Test Identification C Passes Test Passes Test Residue on Ignition 0.25 % max. < 0.05 % Saponification Value Specific Gravity at 25 /25 C Viscosity at 25.0 C, cst Water (H 2 O) 3.0 % max. 0.1 % Organic Volatile Impurities (1) Conforms to USP/NF Conforms to USP/NF (1) The manufacturer has assurance, based on knowledge of the manufacturing process and controlled handling, shipping, and storage of the material, that there is no potential for organic volatile impurities to be present as described in the current U.S.P. In this case "unnecessary testing may be avoided". Meets Ph.Eur. Chemical Specifications Acid Value 2.0 max. 1.3 Total Ash 0.25 % max. < 0.10 % Heavy Metals (as Pb) 10 ppm max. < 10 ppm Hydroxyl Value Identification A Passes Test Passes Test Identification D Passes Test Passes Test Peroxides, meq/1000g 10.0 max. 0 Ethylene Oxide 1 ppm max. < 1 ppm Dioxan 10 ppm max. < 10 ppm Saponification Value Water (H 2 O) 3.0 % max. 0.1 % Composition of Fatty Acids Myristic Acid 5.0 % max. 0.1 % Palmitic Acid 16.0 % max. 7.3 % Palmitoleic Acid 8.0 % max. 0.0 % Stearic Acid 6.0 % max. 1.6 % Oleic Acid 58.0 % min % Linoleic Acid 18.0 % max. 0.1 % Page 36 of 42

37 Linolenic Acid 4.0 % max. 0.0 % Pyrogen* Passes Test Passes Test *The manufacturer has assurance, based on knowledge of the manufacturing process and controlled handling, shipping, and storage of the material that it meets the Ph.Eur. Test Specifications for Pyrogens. Meets JP Chemical Specifications Appearance Passes Test Passes Test ph of 5% Aqueous Solution Identification A Passes Test Passes Test Identification B Passes Test Passes Test Identification C Passes Test Passes Test Identification D Passes Test Passes Test Viscosity at 25.0 C, (mm/s) Specific Gravity at 20 /20 C Acid Value 2.0 max. 1.2 Saponification Value Iodine Value Heavy Metals (as Pb) 20 ppm max. < 20 ppm Arsenic (As) 2 ppm max. < 2 ppm Water (H 2 O) 3.0 % max. 0.1 % Residue on Ignition 0.15 % max. < 0.01 % Color (Gardner) 7 max. 4.2 Odor (Faint) Passes Test Passes Test Water (H 2 O) 0.2 % max. 0.1 % Peroxides, meq/1000g 2.0 max. 0 Endotoxin Concentration (EU/mL) 10 max Organic Volatile Impurities: Free Ethylene Oxide 1 ppm max. < 1 ppm 1,4-Dioxane 5 ppm max. < 5 ppm Microbiological: Total Plate Count (opg) 100 max. < 100 Escherichia Coli Passes Test Passes Test Pseudomonas aeruginosa Passes Test Passes Test Salmonella Passes Test Passes Test Staphylococcus aureus Passes Test Passes Test Yeast and Mold (opg) 50 max. < 50 Suitable for use in the manufacture of parenteral dosage forms. Bulk Pharmaceutical Chemical CRILLET 4 HP TM is a trademark of Croda International Plc. Country of Origin: Manufacturer: USA P Page 37 of 42

38 For questions on this Certificate of Analysis please contact Technical Services at or Mallinckrodt Baker, Inc. 222 Red School Lane Phillipsburg, NJ Phone: Fax: Page 38 of 42

39 Page 39 of 42

40 Page 40 of 42

41 Page 41 of 42

42 Page 42 of 42