ag AUROBINDO RIVASTIGMINE USP Page | No. 1of2 ich Number [2108100482 (Plant Bateh nc no. 2008106650) ALR. No. 20FP02044 Mfg. Date November 2020 | Date of Release Quantity 0.100 Kg Retest Date TEST ION Viscous, clear and colourless to yellow to very. slightly | brown, Figuid. Z | Slightly soluble in water, very | Slightly soluble in water, very soluble in ethanol, acetonitrile, | soluble in ethanol, acetonitrile, _ n-octanol and ethyl acetate. _| n-octanol and ethyl acetate. | Identification a) By IR (Neat) IR spectrum must exhibit | IR spectrum exhibits maxima at maxima at the same | the same wavenumbers as the Viscous, clear and colourless liquid. wavenumbers asthe | Rivastigmine working standard. | Rivastigmine working | | standard. b) By HPLC | The retention time of the major | The retention time of the major |peak as obtained in the|peak as obtained in the { ‘Enantiomeric purity | ‘Enantiomeric purity | [Rivastigmine (R)-Isomer[’ test | [Rivastigmine (R)-Isomer]’ test of the sample solution should Jof the sample solution correspond to that of the | corresponds to that of the Rivastigmine peak inthe | Rivastigmine peak in the system system suitability solution. suitability solution, | 4 | Water (% wiv, by KP, ____| determined on'1.000 2) cea a 0% | Residue on Ignition (% wi, ; ; > | determined on 1.0.2) Notmore than 0.1% | 200% Enantiomeric Purity 6 | [Rivastigmine (R)-Isomer] (by | Not more than 0.3 % 0.002 % HPLC, % wéw) Prepared By | Cheeked By Approved By Name B. Nirmala ‘T.Ramesh Babu T. Satish Kumar (iby foo | 2n0¥/2021 27101/2021 Unit VIEL: Survey No, 10 & 13, Gaddapotharam Village - 502 319 IDA-Kazipally, Jinnaram Mandal, Sanga Reddy District, T.S. INDIA. Tol: +91 0458 277 114115, Fax: + +91 8458.27 115 Regu. OFF: Plot No. 2, Maitrivhar, Ameerpet, Hyrabad - 500 038, T.S., INDIA. Tel: + «91 40 6872 5000 Fax + +91 40-2374 6839, 2374 1080 PAN Wo. ANBCA7366H www.aurobindo.com& AUROBINDO CERTIFICATE RIVASTIGMINE USP Batch Number | 2108100482 (Plant Bateh n © | Product Name Mfg. Date November 2020 Date of Release | 21/11/2020 Quantity 0.100 Kg, Re it October 2023 TEST | Related Substances by HPLC 7 7 (% wiwy* © Phenol Impurity [USP | Rivastigmine Related Not more than 0.3 % 0.0001 % Compound C] © Nor Impurity [USP Rivastigmine Related Not more than 0.1% 0.03 % Compound B] © Any other Not more than 0.10.% 0.002% |_* Total ___| Not more than 0.5 % fa | ee eee 032176 | Assay (By HPLC, % wiw, as 9 CiaHz2N2Ox, on_ anhydrous “and | NOt less than 98.0% and 99.3% |__| n-Heptane-free basis) vot more than 7 | - | 9 1% ee Content (By GC, Not more than 6.0 % Notdetected | % Chemical names of Related substances: » 3-[(18)-1-(DIMETHYLAMINOETHYL)|PHENOL [PHENOL IMPURITY] [USP RIVASTIGMINE RELATED COMPOUND C] > 3-((L8)-1-(DIMETHYLAMINO)ETHYLJPHENYL =DIMETHYLCARBAMATE [NOR IMPURITY] [USP RIVASTIGMINE RELATED COMPOUND BI » 3-[(1R)-1-DIMETHYLAMINO)ETHYL|PHENYL ETHYL(METHYL)CARBAMATE, [RIVASTIGMINE (8)-ISOMER} REMARKS : The material complies as per the above specifications. Storage Conditions: Preserve in airtight container, under nitrogen gas, protected from light, Store at a temperature of 2°C t0 8°C. Prepared By Cheeked By Name B. Nirmala | 8) Date 27101/2021 Signature AUROBINDO PHARMA LTD Unit VII: Survey No, 10 & 13, Gaddapotharam Vilage - 502 319 IDA-Kazipaly, Jinnaram Mandal, Sanga Reddy District, T.S. INDIA. Tol: +91 8450-277 114 15, Fax: + +91 8458 277 115 Regd. Off: Plot No. 2, Maitivihat, Ameerpet, Hyderabad - 600 038. T.S, INDIA. Tel: + +91 40 6672 5000 Fax + ¥81 402374 6833, 2374 1080 PAN Wo. ARBCA73OGH www. aurobindo.com Format No. : HQAOSD-FO1-00