Hetero Drugs Limited SINos, 213, 214 & 255, Bonthapally Village Jinnaram Mandal, Medak District, Andhra Pradesh, INDIA. Phone : + 091-8458-275314/ 275777 Fax:#91-8458-275271 CERTIFICATE OF ANALYSIS Product Donepeil hydrochloride (Fox) Referense STP No, =DP-001-00 Batch No p0010409 Referense In-house Daic of Manufacture April - 2009 Batch Quanity 23.10 Kes Aalytiesl Report No, : DPOO109 Date of Analysis 30/04/2009 Retest Date September- 2009 Stas Conified sxe “Fest Specifications Results Reference 1 esrnion A whit to off whit crtaline powder ‘tite csalie | Visa inpetion 5 [Siehiy soluble in wate, chloroform, methanol and Spatinaly : : 2 |Solubitiy enema ous Complies ‘Visual inspection IR: The Inia Red absorpion speouum ofthe Haely ground sample in KCI should exhibit maxima nly atthe same wave | Matches withthe | gy cag7 gy lengths as that ofa similar preparation of Donepezil standard speerum | USP nydrochorde (Form-IIf) working standard 3 Idenfication by HPLC: The retetion tie ofthe major peek inthe chromatogram of the assay preparation should coresponds to | Matches withthe ae that in the chromatogram of the standard preparation, as obtained] standard Naito the assy on anhytrous basis by HPLC. fa Ee (Chloride test: Should respond to the ehovide est. Complies UsP<191> Te difactogram ofthe test sample should maich wih hat of [Matches wih th andar ag eee Donepe!l hydrochloride Porme(I) working star dihactogram ust saat 5, [Water content by KE [Not more than 1.0% 0.50% ww UsP-<921> 6 [Suiphated ah [Should nor be more than 0.2% whe O12 % wi USP <281> 7 [Reavy metals Should not be more then 0.002 % whe ass than 0.002% wie | __USP=231 > _[Chovide content [Should be between 8.1 0 8.9 % wh 55% why usP 9 [Palladium content [Should not be more then 5 ppin Inhouse 10 [Platina content [Should not be more than 5 ppor Tichouse 2.3-aihydto-5,6-dimethony 2-[4-pyidinyl)methyl}-1-inden-1- lone Impuriyee Should not be more than 0.15 % 2,3-aydto-5,6-cimethoxy-2-(t-piperinymetiyi]-1H-inden- aaa Jone hydrochloride Impurity-B Should not be more than 0.15% is 1 [Related substances by [1 -penayi-tf3-(benzyloxy)36-dimethoxy-1I-2-indenyl| sp <621> HPLC methlpiperidine hydrochloride Not detected In-house limpurgy 12 ee PEPE gy [Notes than 98.0% and aot more han 102.0% 8.8% wh usP <62 Mehanel ‘ot moie than 3000 ppm ppm 1g. [Residuat sotverishy [Acetone ‘Not more than 5000 pom 378ppm___ | USP-<467> in jact Dishloromethane Not more than 600 ppm Not detected towse [Ethyl acctate Not more than $000 ppm Not detected woos BROLY Date Zoloyl 009 comnts: ff] cee Ly Dat Dat : 2ofoyl20e4 So\ou | 20%) TEDRCONTIT DS TCR dts USBI Page ofey 25 Hetero Drugs Limited ft] S05, 213,214 & 255 Bonhapaly Village, Jianram Mandal Medak Distt, Andhra Pradesh, INDIA Phone 091-8458-275314/ 275777 Fax! 18458-27527 CERTIFICATE OF ANALYSIS Pome Dope ce Perm) Teloea SPN INTO Dao “presto tote “Into Decorate: ap 29 Bach ovniy 2870s "No potential forthe class-1 solvents as specified by ICH or < 467 > USP tobe present in Donepezil hydrochloride (Form-I0), as they are not used inthe manufaeturing process. The material if tested for these solvents, wll comply with the established standards The product conforms tothe above Speci Date comailetov AY) cesta 9 Authorised santo CH Od De olpifansn 1 at Date sol outros QGDP-COA-DOI-T fective date 05/04/2009 Page 2 of 2