Certificates of Analysis Table of Contents
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1 Certificates of Analysis Table of Contents Component Page Dimethyl sulfoxide, anhydrous 2 Potassium hydroxide, 85% 3 Ethyl alcohol, USP 200 proof 5 0.9% Sodium Chloride for Injection, USP 6 Ethanol, dehydrated 7 Sterile vial 10 ml 10 Sterile Millex-GV filter (0.22 µm, 4 mm diameter) 13 Sterile Millex-MP filter (0.22 µm, 25 mm diameter) 14 Sterile needle (21 G, 2 ) 15 Sterile needle (20 G; 1.5 ) 16 N-desmethyl-NOP-1A 17 NOP-1A Reference Standard 18 Water, HPLC grade 19 Acetonitrile, HPLC grade 20 Ammonium formate, % 21 HPLC column (analytical, Phenomenex Luna C-18; 10 µm; 4.6 mm 250 mm) 22 HPLC column (semi-prep, Phenomenex Luna C-18; 10 µm; 10 mm 250 mm) 24 1% Oxygen in Nitrogen Gas 25 Nitrogen, Ultra High Purity Carrier Grade 26 Helium 27 Iodine 28 Sterile Water, Injection, USP 29 Endosafe PTS Cartridges 30 Eppendorf Sterile Pipette Tips 31 Bactec Standard Anaerobic/F Medium 33 Bactec Standard/10 Aerobic/F Medium 35 Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 1 of 37
2 Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 2 of 37
3 Dimethyl sulfoxide, anhydrous Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 3 of 37
4 Potassium hydroxide, 85% Product Name Potassium hydroxide, ACS reagent,? 85%, pellets Product Number Product Brand Sigma-Aldrich CAS Number Molecular Formula KOH Molecular Weight TEST SPECIFICATION LOT 05611JD RESULTS APPEARANCE WHITE PELLETS WHITE PELLETS TITRATION 85.0% KOH (MINIMUM) (WITH HCL) 89.73% KOH (WITH HCL) * 2.0% K2CO3 (MAXIMUM) 0.50% K2CO3 * ICP ASSAY CONFIRMS POTASSIUM COMPONENT. CONFIRMS POTASSIUM COMPONENT CALCIUM 0.005% (MAXIMUM) <0.001% * CHLORIDE 0.01% (MAXIMUM) <0.005% * IRON 0.001% (MAXIMUM) <0.0005% * HEAVY METALS 0.001% (MAXIMUM) (AS AG) <0.001% (AS AG) * MAGNESIUM 0.002% (MAXIMUM) <0.001% * SODIUM 0.05% (MAXIMUM) <0.01% * NITROGEN COMPOUNDS 0.001% (MAXIMUM) <0.001% * NICKEL 0.001% (MAXIMUM) % * PHOSPHATE 5 PPM (MAXIMUM) <3 PPM * SULFATE 0.003% (MAXIMUM) <0.001% * AND/OR * SUPPLIER DATA MATERIAL TYPICALLY CONTAINS 10%-15% H2O * SUPPLIER DATA REVISED DECEMBER 17, 2003 JSB * SUPPLIER DATA AND/OR MEETS REQUIREMENTS OF ACS 9TH ED MATERIAL TYPICALLY CONTAINS 10%-15% H2O REVISED DECEMBER 17, 2003 JSB RECOMMENDED RETEST JULY 2007 MEETS REQUIREMENTS OF ACS 9TH ED MEETS REQUIREMENTS OF ACS 9TH ED Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 4 of 37
5 EXACT REPLACEMENT FOR PRODUCT CROSS PRODUCT NUMBERS P6310 REFERENCE INFORMATION QUALITY CONTROL JULY 2005 ACCEPTANCE DATE Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 5 of 37
6 Ethyl alcohol, USP 200 proof Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 6 of 37
7 0.9% Sodium Chloride for Injection, USP Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 7 of 37
8 Ethanol, dehydrated Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 8 of 37
9 Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 9 of 37
10 Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 10 of 37
11 Sterile vial 10 ml Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 11 of 37
12 Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 12 of 37
13 Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 13 of 37
14 Sterile Millex-GV filter (0.22 µm, 4 mm diameter) Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 14 of 37
15 Sterile Millex-MP filter (0.22 µm, 25 mm diameter) Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 15 of 37
![Sterile needle (21 G, 2 ) Document 8: [ 11 C]NOP-1A](/docs-images/79/79909786/images/16-0.jpg "for Injection: Certificates of Analysis Page 16 of")
16 Sterile needle (21 G, 2 ) Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 16 of 37
17 Sterile needle (20 G; 1.5 ) Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 17 of 37
18 (S)-3-(2'-fluoro-6',7'-dihydrospiro[piperidine-4,4'-thieno[3,2-c]pyran]-1-yl)-2-(2- fluorobenzyl)propanamide (N-desmethyl-NOP-1A) Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 18 of 37
19 (S)-3-(2'-fluoro-6',7'-dihydrospiro[piperidine-4,4'-thieno[3,2-c]pyran]-1-yl)-2-(2-fluorobenzyl)-Nmethylpropanamide (NOP-1A Reference Standard) Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 19 of 37
20 Water, HPLC grade Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 20 of 37
21 Acetonitrile, HPLC grade Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 21 of 37
22 Ammonium formate, % Product Name Ammonium formate, % trace metals basis Product Number Product Brand ALDRICH CAS Number Molecular Formula HCO 2 NH 4 Molecular Weight TEST SPECIFICATION LOT 05507EJ RESULTS APPEARANCE MOIST WHITE CRYSTALS MOIST COLORLESS CRYSTALS INFRARED SPECTRUM CONFORMS TO STRUCTURE. TITRATION 96.5% (MINIMUM) (WITH HCLO4) 99.3% (WITH HCLO4) TRACE ANALYSIS, ICP PURITY 50 PPM (MAXIMUM) TOTAL METALLIC IMPURITIES PURITY BASED ON TRACE METALS ANALYSIS AL 0.3 PPM; CA 0.4 PPM; NA 0.4 PPM; ZN 0.1 PPM > % BASED ON TRACE METAL ANALYSIS QC RELEASE DATE MAY 2008 Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 22 of 37
23 HPLC column (analytical, Phenomenex Luna; 10 µm; 4.6 mm 250mm) Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 23 of 37
24 HPLC column (semi-prep, Phenomenex Luna C18; 10 µm; 10 mm 250 mm) Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 24 of 37
25 Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 25 of 37
26 1% Oxygen in Nitrogen Gas Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 26 of 37
27 Nitrogen, Ultra High Purity Carrier Grade Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 27 of 37
28 Helium Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 28 of 37
![Iodine Document 8: [ 11 C]NOP-1A for](/docs-images/79/79909786/images/29-0.jpg "Injection: Certificates of Analysis Page")
29 Iodine Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 29 of 37
30 Sterile Water, Injection, USP Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 30 of 37
31 Endosafe PTS Cartridges Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 31 of 37
32 Eppendorf Sterile Pipette Tips Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 32 of 37
33 Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 33 of 37
34 Bactec Standard Anaerobic/F Medium Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 34 of 37
35 Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 35 of 37
36 Bactec Standard/10 Aerobic/F Medium Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 36 of 37
37 Document 8: [ 11 C]NOP-1A for Injection: Certificates of Analysis Page 37 of 37
[ 11 C]Mes-IMPY FOR INJECTION: CERTIFICATES OF ANALYSIS
![[ 11 C]Mes-IMPY FOR INJECTION: CERTIFICATES OF ANALYSIS](/thumbs/81/83372839.jpg "[ 11 C]Mes-IMPY FOR INJECTION: CERTIFICATES OF ANALYSIS")
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
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