Answers That Matte Document Name: VL7640001KO_C368281F_KR Description: COA for VL7640001KO_C368281F_KR Document Version: 1 Current Status: Effective Effective Date: 2014-12.08T13:38:05 Reviewer Role - Name, Date & Time Quality Assurance - Beadle Debbie A - 2014-12-08T 13:10:55 Approver Role - Name, Date & Time Quality Assurance - Wallen Jeanne Louise - 2014-12-08T 13:34:32 Delegations - Name, Date & Time NA li Lilly and Company CONFIDENTIALLilly Corporate Center Indianapolis, IN 46285 usa Z Phone: (317) 276.2000 we ily.com 08-Dec-2014 Certificate of Analysis To whom it may concem, This's to cettiy that the data contained herein are assay results obtained by Eli Lily and Company from tests performed on this product Material: VL7640001KO Material Name: ALIMTA FINJ 100MG 10ML X1VIAL KO ‘Trade Name: Alimia (Pemetrexed For Injection) Batch Number: C368281F Bulk Batch Number: 368284 Country: South Korea Component Result Unit Acceptance Criteria Sect Endtonins 00200 eum Sectel Ertonins <2 017 cis ss MMT reference suspension Cnty = Pass Trt suspension Ht tr coe Pass-NT V3 Orv at Color = "Pets -NUT ¥4 or Gy ar aey ase The saris etorconsine lderety = "Pass The samp tation tre ust mus comear wen rat one compare tnt ote reteronce tana cory Pass. The Rtmuat cams with corny #368 The At ust compare wih at Inatr thereterenes stance, tre referene sansa Largest Unset npunty 0050 Parcnt gost Unescetiea input <= 0.20 (Soypenreatspace «2 arcane ‘Onygen Heacspace < 10 Prius Pats Meets USPPNEWEPLI tet Panicle Mater" Pats - Metts USPIPREWISPLP Panacexed Fs Red (canpouna 1000 PecentofLABEL Pemavere Fee eid (Compound 281514) 5:5) cunt [average] >= 650 AND Persad Fras Acts (Compauns731514average = 1050 os a pereae nO ptcere Physics Aepaarance 28s Whee atherignt yetowish Physi Azpearence = Pase- nt ester or gaanyliowsshonttzed sole slowsh er sresnytowisn yopizes sols" Recontiaton Tine 2 Ssonas Feconsttvin Tnalavragel <= 100 Sti Pass Moets USPPREWGOIRP Test Stnity "Pass - Wee USPIPREWIIPIP Tee tory OF Dosage Unte Pass Moos the Pau, USEANF oF Untomiy Of Dosage Units = "Pass Mees ne Pathos neu, USP or JP ato tee 2€ Pocentwiw Water 60 Date of Manufacture: 15-Sep-2014 Release Date: 05.Dec-2014 Expiration Date: 2016 09 14 ‘Comments ‘The medicinai product has been manufactured in accoidance withthe principles and guidelines of Good Manufacturing Practices appropriate forthe intended county Very truly yours, El Lily and Company This document has been electronically signed. Please see the attached signature page for document approver and effective date. Batch Number: 0368281F Material: VL7640001KO Page 1 of Date Printed: 2014-12-08714:09:24 08 Effective as of 2044-12-08113:38: VL7640001KO_C368281F_KR Version: 1