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CI-iTROSWTENCE Cambrfege Sclcnce Park Milton Road Cambridge CIM 4WE ' England Tel. +a4t01122) a20470 iar.. +-a4 t01[ 2:y 420440 cE, RTXFICATE OF ANALYSIS PRODUCT: (E)-Mctanicotine fumaratc Batch No.: B1060 Test -] Requlrements ResulLs 1) Appearance A white to buff- 0ff-white, fine• - coloured solid crystalline powder 2) Identification by IR Spectrum corresponds Spectrum corresponds spectroscopy with that of reference with that of reference standard standard 3) Identification by'H-hiMR Spectrum corresponds Spectrum corresponds with that of reference with that of reference standard standard 4) pli 4.0 - 5.0 4.47 5) Related Substances by TLC No impurity greater No secondary spots than 19o w/w detected 6) Related substances by fiPLC Nicotine Not more than 0.5 0 <0.190 wlw Other Impurities No individual impurity RT == 2.7 nun, 0.485'0 greater than 1% wJw RT = 3.1 min. 0.49% RT =12.4 min, 0. 10 % Total impurities not to Others: 0.27% exceed 5% w/w Total = 1.34 0 ) -isonter conrep.t by OC 7)(7 Not more than :.5 0 0.5? k F wlw _ - ---- . _.~------_J.~ aw M cuals _- . .~_ - -- _Not more than 20pPm < O.ik)1`o wd.c Page 1 of 3 ' J FM No. 32101 4pcerolm e+l.M a t/<,M1+<bfzs r.r.dn MG14>)

CERTIFICATE OF ANALYSIS PRODUCT: (R)-iVtetvticotine Cumarate Batch No.: f11060 RfT1:ST DATE: CERTIFICATE NUMBER: DATE OF ISSUE: Stability not detennined CA951108 11 September 1995 Prepared by: ~ ~ ~ it~ 2u~ v 1 ....~...~ ................. .. ..................................................... Job Title: Release Authorixation: C> ` t~~ \ . Job TiUe: " ' C0SPaeW [1EEE:I:1ETTj

CER'FXr+'XCATE OF ANALYSIS PRODUCT: (I's)•Melanicotinc fumarate Batcb No.: B1060 Test F Requirements ~ Results 9) Sulphated ash Not more than 0.1 `Io < 0.1% w!w ~ w/w 10) Residual Solvents as toluene, Total not more than Toluene 2ppm ethanol and THF 1000ppm Ethanol 215ppm THF 20.ippm Total 420ppm 11) Water by KF Not more than 2.5% 0.81 % w/w ~ w/w 12) Assay by HPLC ^ Not less than 95 % w/w 98.90 awlw J on the,dried,hasis.__.,. ~ This batch of (E)•Metanicotine, fumarate meets the requirements of specification number S1611001/02. This batch of (E)•Wletanicotine, fumarate is NOT FOR HUMAN USE. THE THERMAL STABILITY OF THIS MATERIAL HAS NOT i3EEN DETERMINED ( CA951108 l Paee2 of 3