LABORATORIOS SERRAL GRUPO FARMACEUTICO SOMAR S.A. DE C.V. PLANTA GHALCO: Camino Real a Cocottian SIN, Esquina Constucién 5 de Febrero, Zona Indra Chalco Serral Doin LOTE: E1911978 PRESENTACION: Tabletas DOSIS: 1 mg PROCESO: Transferencia Analitica PRUEBA: Disolucién ‘Acquired By: GGONZALEZM System Name HPLC WATERS2 Column Name: BDS Hypersl C18 Column ID: P-32-4 ‘Acg. Method Set. FINASTERIDA_DIS Project Name: 20191AT\AE\FINASTERIDA_AE ‘Sample Set Method 17SEP19_DIS Processing Method: Finasterida_Dis Datos Generales de Estandares NOMBRE: Finasterida Lote: R027L0 PUREZA (%): 99.7 ANALIZADO POR: APROBADO POR: FIRMA: FIRMA: —$ —$_ ____ FECHA: — 2h ee fig recta: — gate tl? ESTANDARES DE ADECUABILIDAD Name: Finasterida SarpleNare| Vial|irj| Chanel | Name | RT |Colea|Pite | Area | maim | [4 [sto tape (2 |1 |Woss6ChA| Finasteride 326/10) S889) 165127) ooott [2 [sto 1aDE |2 | 2 |woss9Cha| Finasteride 326/ 10/6678 166180| O.0ot1 | 3 | STDIADE (2 |3 | W24B9ChA| Finestiride 326, 10 $675) 164646| O.0DtT 4 [STO 1ADE [2 [+ | waren | Fienteica [325/10] S60 | 16407 [co 5 |STDTADE (2 |5 |WO4S9CKA Finasteride | 325/10 $683) 164698 O00T1 6 |STO1ADE 2 (6 | WAS9CMA Finasteride 325 1.01 5600/ 164100] 00011 ean ‘325 10) 5661 164739) o0o1t ‘Sid Dew 00/00) so) 713) 00 % RSD S 00] 04) 01) 02] 00 Report Method Name: Finasterida_Dis Printed 02:21:46 p.m. America/Mexico_City martes 24 de septiembre de 2019 Page: 1 of 11LABORATORIOS SERRAL GRUPO FARMACEUTICO SOMAR S.A. DE C.V. F PLANTACHALCO: Carino Reals Casa SN xan Corettucn de Fbreo, Zen dil Caen Serral LOTE: £191197A PRESENTACION: Tabletas DOSS: 4 mg PROCESO: Transferencia Analitica PRUEBA: Disolucién ESTANDARES DE CONFRONTACION __ Name: Finasterida 7 SarpleNare|Vil|irj| Chane! | Name | RT |Colso| Pate | Area 41 [StO2__|3_|1 | WeAeeChA| Finasteride | 328, 1:1 S617 168257 2 [STD2 32 | WOAOCA | Finestwida | 32511, 5622, 169659 ‘Mean 325] 11) 5818) 163485 ed Dex I | ao] ao) 35) 200] ‘%RSD [oo] a1] on ESTANDARES DE CALIBRACION Name: Finasterida SarvieNave] Val[Fi] Chanel | Nore | RT [Colo|Ptae | Aves | maint 1 (STD TADE 2/1 | WoABoChA Finasteride | 32610 s6e9|165127 | OoDtt 2 STDIADE (2 |2 | W2489CNA Finasterida| 325/10 8678 165180| O0OtT 3 |STOTADE 2 [3 |W2WB0ChAFinasterida | 326° 10/6875 To%e4« OoDtt 4 STOTADE 2/4 |WOAG0CA | Finstwiga 325/10) 680 168627 OoDtt 3 [sro 1ADe 2/5 |WoHOCM Fn 35/10) 56/16 | ono 6 _[STOIADE (2 [6 |WOGOCKA Finasteride | 325, 10/ 56a0/ 164180) O0OKT 7 [stor [2 [1 |Wat6OCKA Finasteride 326, 1.0) 560) 162287/ oott Mean : 323,10, S681, 164383] O00tt 3a. Den Er a0) a0 45) seas] a0 “9680 L 00/04) 01, 08] 00 Report Method Name: Finasterida_Dis Printed 02:21:46 p.m. America/Mexico_City martes, 24 de septiembre de 2019 Page: 2of 11LABORATORIOS SERRAL GRUPO FARMACEUTICO SOMAR S.A. DE C.V. PLANTA CHALCO; Carino Real a Cocotlan SIN. Esquina Constucion § de Febrero, Zona Invi Chaleo Serral FINASTERIDA LOTE: E191197A PRESENTACION: Tabletas DOSIS: 1 mg PROCESO: Transferencia Analitica PRUEBA: Disolucién MUESTRAS Name: Finasterida / Sarwie ; = wre | FO] PP pe) x leon | | Ware (Mit is) crt | nare | Rr | cco] raw | | fo) | ay | Ase | % [mot] 1 [EIBTG7ADISMi/4 1 | WOMOChA Finstwida 325/10 | 699/100) sooo | 10000 168172 680| 0860 | 2 /EIOTISTADS.M2/5 1 |WOM9CHA Finasteride 325) 10 | 564 | 100) eno | tom 168017 851 O881 3 /EVOTISTA.DIS.M3|6 1 | WOAG9CHA Finasteise 925/10 6751 100, sono | 100) 180157 S58 O8EE 4 _[ETOTISTA.DIS M4|7_ 1 | WO2ABOCRA| Finasteride 925/10 | 674® 100, eoO0 | 1.0000) 161056] 987) 0967 5 /EVOTISADIS.MS/8 1 | WOAGOCKA|Finatvida 3251 10 S607, 100 e000 | 1000 15565] su9) om © /EVOIIEPADIS.M6|8 1 | WOGOCKA|Finastvida/325) 10 S657) 100/ sono | 1000) 158556] S52 oss2 ‘Mean : 325/ 10 | sa [ 150025] 96 | 096 | 3s Dew oo 00 | 283 785/14) 00 %RSD | I [eo | 04 | os [Las [as| 18 | rc a 01} a occ} a 2 000: 2 oto: oor 0001 -0.010- T 7 I -0.010}—r T ——+ ‘0 20 40 0 00 20 am 600 Mires Mires Val SarpleNare DI: Date Acre Tac. 17 Via SapleNare Dt: Date Acard Tosca. 17 de Sees se 201808278 PM AmercaNosca Ciy — —_—_Selrbr Go 20198349 PM Arericohtein Cly- Processing Method Frater Die Processing Method Fister, Dis Report Method Name: Finasterida_Dis Printed 02:21:46 p.m. America/Mexico_City martes, 24 de septiembre de 2019 Page: 3of 11LABORATORIOS SERRAL GRUPO FARMACEUTICO SOMAR S.A. DE C.V. PLANTA CHALCO: Camino Real a Cocotian SIN, Esquina Constiucén 5 de Febrero, Zona insrial Chalco Serral Sst t7.4 LOTE: €191197A PRESENTACION: Tabletas DOSIS: 1 mg PROCESO: Transferencia Analitica PRUEBA: Disolucién rs 5 00 ° 0.040} ono} g! 2 2 000] 3 a i 104 oe f —_ a 200 — 200 400 000 260 400 600 Mites Wintos Vil 2 SarleNae STD 1 ADE: Dat Acuied Va 2 SarpieName STO 1 ADE: Date Aoqured “ues 17 ce Septet do 201902449 PM “Tovey 17 do Soponber do 2019 C247 Pu ‘arericaMosc, Ci Processing Method ‘nrericatecn Cy Processing Method Firat Dis Finan, Di aso ee oo! ooo! 0 ol Zo 8 oon } a —~ = — 000 200 400 00 Mines Vial 2, SarpieName STD 1 ADE: Date Acquired Mial2; SarpieName STD 1 ADE: Date Acquired “Tuesday, 17 de Septerber de 2019 0855-46 PA “Tuesday, 17 de September de 2018 100400 PM ‘AmericaMeico City, Processing Method AmericaMeico_Cly Processing Method Finasteride Dis Finastrida Dis Report Method Name: Finasterida_Dis, Printed 02:21:46 p.m. America/Mexico_City martes, 24 de septiembre de 2019 Page: 4 of 11LABORATORIOS SERRAL GRUPO FARMACEUTICO SOMAR S.A. DE C.V. PLANTA CHALCO: Camino Real a Cocoitlan SIN. Esquina Consttucién 5 de Febrero, Zena Indisrial Chaleo SUS. LOTE: 1911978 PRESENTACION: Tabletas DOSIS: 1 mg PROCESO: Transferencia Analitica PRUEBA: Disolucién 050 080 aor} a0} i 2 om! i 2 $ oor} 3 core} a 2) oom} _ 0010 = | -so%01—_—— oo 0 20 «to 00 000 20 ato 600 Mites Mines Vial 2, SanpieName STD 1 ADE; Date Acquired Vial 2; SonpleNare STD 1 ADE: Date Acquired “Tuesday 17 de Septebet de 2019 10:11:15 PM Tuesday, 1 e Soper de 2010 101630 PM ‘Ametcaeico, City Processing Method ‘rercaesico, Gi Processing Metres Fines Ds Finasteride Ds oso oso 7 000 o0%| ooo} = 1 a. 2 cc} g| ct 3 oto} i aor} 5 z | El goo} —~~——_—~H 0000} ———~_ #4 -—— -0010 Se 000i; + - ooo 20 ato 00 00 bo ato 00 Mindes Mintes Vial; SampleName STD 2 Date Acaited Tossa, 17 Vial 3; Sonpleare STD 2: Dato Aoquied Teese 17 de Spterber de 2019102545 PMA eo Septter do 2018103501 PM ~ Americaeco Ci, Processing Method ~~ recateon Ci Processing Metod Finastrida Dis Finasteride Ds Report Method Name: Finasterida_Dis Printed 02:21:46 p.m. America/Mexico_city martes 24 de septiembre de 2019 Page: 5 of 11E LABORATORIOS SERRAL GRUPO FARMACEUTICO SOMAR S.A. DE C.V. < 1 PLANTA CHALCO: Camino Real a Cocstitan SIN. Esquina GonstitusionS de Febrero, Zana inurl Chalco Serra FINASTERIDA LOTE: E194197A PRESENTACION: Tabletas DOSIS: 1 mg PROCESO: Transferencia Analltica PRUEBA: isolucién 080 - 0080, 0000} 00104 ono} 0304 =| 2 owl g 2 oj oro} 3 00103 a coro: Ef ~ oe -010+ — eee 0010+ It . 1 000 2bo 400 6 ovo 20 ab 800 Mines Minos ial 4 Sameleave E1S11574,DIS_Mt; Date Acaired ial §; Sample E121187A,DIS_M2; Date Acquired __Tuvsday 1 de Seton de 2019 104016 PM “Tuesday, 17 de Seber do 2019 14722 PM ‘ericaltoio, Cig Processing Method ‘ericatesico_ City Precessng Method Finastrigs Finasteride Dis 0050 060 ~ ooo} 000} oso} caso: gl gl 2 0000: § 2 ono] g 1 8 3 0104 i 010+ Fi 9.000} — sa sk 0010} —- —_— 0010+ - ‘m0 20 40 600 000 200 400 00 Minds indos Vial 6, SanpleName£191197A.DIS. Ms} Date Acgured Vial 7: SarpleName E191197A_DIS_ Mé; Date Acquired “Tuesday, 17 de Seplerber co 2018 10:56 PM “Tuesday, 7 de Setomber do 2019 11.0202 PM -Arvericahteico Ci, Processing Methed seericattesco City, Processing Method Finasterica Dis Finasteride Dis Report Method Name: Finasterida_Dis Printed 02:21:46 p.m. America/Mexico_City martes, 24 de septiembre de 2019 Page: 6 of 11LABORATORIOS SERRAL GRUPO FARMACEUTICO SOMAR S.A. DE C.V. PLANTA CHALCO: Carino Real a Cocuilan SIN. Esquina Consttucion 5 de Febrero, Zona indsral Chalco ait by8 LOTE: E191197A PRESENTACION: Tabletas DOSIS: 1 mg PROCESO: Transferencia Analitica PRUEBA: Disolucién oes 0080: o 0.040} 0 0.0004 zo 2 com! oon oot} : fo 0010+ oo 0010 - —- 000 200 400 600 00 200 400 600 Mines Mises Vie; SarpleName E191197A_DIS_MS; Date Acquired Vial SarpleNare E191197A_DIS_ M6; Date Acquired “Tunsdy, 17 de Septerber de 2019 1108-17 PM “Tuesday, 17 de Septeriber de 2019 11:16:32 PM ‘AmericaMesico City, Processing Meted ‘AmericaMexco City, Processing Method Firasterida Dis Fioastoria Die Minges ‘Vial 2; SampleNVame STO1; Date Acquires Tuesday, 17 de September de 2019 112349 PM ‘AmericaMesico_Cily Processing Method Finastrica Dis Report Method Name: Finasterida_Dis Printed 02:21:46 p.m, America/Mexico_City martes, 24 de septiembre de 2019 Page: 7 of 11= LABORATORIOS SERRAL GRUPO FARMACEUTICO SOMAR S.A. DE C.V. PLANTA GHALCO: Camino Real a Cocottan SIN. Esquina ConstitucionSde Febrero, Zona Indusrial Chalco La asia eyay LOTE: £191197A PRESENTACION: Tabletas Dos! PROCESO: Transferencia Analitica PRUEBA: Disolucién Instrument Method: FINASTERIDA_DIS Stored: Friday, 13 de September de 2019 08:19:42 PM America/Mexico_City Method Information _ Method Comments FINASTERIDA_DIS. Method Modified User GGONZALEZM Method Locked No Method Id 1398, Old Id Method Version 3 Method Edit User Source S/W Info Empower 3 Software Build 3471 SPs Installed: SR2 Hotfix 2 DB ID: 2273282026 W2489 Instrument Setup Wavelength Mode Single Wavelength Lamp On On Channel A Comment Wavelength 220(nm) Sampling Rate ‘(pointssec) Data Mode Absorbance Time Constant 2.0000(sec) Auto Zero On Wavelength Change Maintain Baseline ‘Auto Zero On Inject Start Yes Analog 7 Senstivity 2,0000(AUFS) Chart Polarity —_—Posttive (+) Voltage Offset (mv) Enable Chart Mark Yes Run Events Yes Pulse Width 1.0(se0) Rect Wave Period 0.2(sec) W269045 Instrument Setup Ls Report Method Name: Finasterida_Dis Printed 02:21:46 p.m. America/Mexico_City martes, 24 de septiembre de 2018 Page: 8 of 11LABORATORIOS SERRAL GRUPO FARMACEUTICO SOMAR S.A. DE C.V. PLANTA CHALCO: Camino Real a Cocotilan SIN. Esquina Consitucién S de Febrero, Zona Indusrial Chaco aaa 18)-4 LOTE: E191197A PRESENTACION: Tabletas DOSIS: 1 mg PROCESO: Transferencia Analitica PRUEBA: Disolucién Instrument Status. On Channel Name 2690/5 Description Use Channel Monitor Off Monitor Parameter System Pressure Strole Volume 130uL (flow rates <= 10.000 mL/min) Chart Out A Syringe Draw Rate Normal Depth Of Needle 0.0 Degas Mode On Pump Mode Isocratic Flow 1.000 A 0.0 %B 0.0 %C 0.0 %D 100.0 High Limit 5000.0 Low Limit 0.0 Enable Sample Temp True Enable Column Temp True Bubble Detect Tne Pre Column Volume 0.0 Sample Temp Target 20.0 ‘Sample Temp Range 5.0 Sparge A 0.0 Sparge B 0.0 Sparge C 0.0 Sparge D 0.0 Column Temp Target 20.0 Column Temp Range 5.0 Flow Ramp 2.00 Column choice No Change Column Equil Minutes 0.00 Needle Wash Normal Switch 1 No Change Switch 2 No Change Switch 3 No Change Switch 4 No Change Use Events False Solvent A AGUA Report Method Name: Finasterida_Dis Printed 02:21:46 p.m. America/Mexico_City martes, 24 de septiembre de 2019 Page: 9 of 11LABORATORIOS SERRAL GRUPO FARMACEUTICO SOMAR S.A. DE C.V. PLANTA CHALCO: Carino Real a Cocotlan SIN. Esquina Constucin 5 de Febrero, Zona Inusral Chaco s ral Last 17.8 LOTE: £191197A PRESENTACION: Tabletas DOSIS: 1 mg PROCESO: Transferencia Analitica PRUEBA: Disolucion Solvent B METANOL. Solvent C ACETONITRILO Solvent D. FASE MOVIL Revision History Version 3 Friday, 13 de September de 2019 08:19:42 PM America/Mexico_City User GGONZALEZM Version 2 Friday, 13 de September de 2019 08:14:36 PM America/Mexico_City User GGONZALEZM Version 1 Friday, 13 de September de 2019 06:19:14 PM America/Mexico_City User GGONZALEZM Created method 'FINASTERIDA_DIS’. FINASTERIDA D'S Insument _FINASTERIDA DIS INASTERIDA_DIS |Instruvent | FINASTERIDA DIS_ 3/FINASTERIDA DIS Instrument FINASTERIDA DIS __Method Version Summaries E Medd Daie | Mabaded ser | ato aded eho) 4 Fi 9 Sepebe de 201908142P ArercaNesco_Ciy GGONZALEZM | No 1388 2 iy Sate Ge 2019081498 PM Arica Cy /GGONZALEZM | No 788 | | Fey. 1d Sse de 201806 1814 Arse, Cy GGONZAIEZM No | | Ott | Method Version | 2: Empower SotereBul471 SPs insta 2 Hes 2 OB: 27205 2 Enpover 3 Sars Bl 47 stad SR2 Hoth 2 OB I: ZTE 1 Enponer Soare Bul SPs stalled SR2 Hot 2OBID: ZTE | [Erne sire Bui 71 SPs nis Sa Hatix2 DBD: zreeaas | Report Method Name: Finasterida_Dis Printed 02:21:46 p.m. America/Mexico_City martes, 24 de septiembre de 2019 Page: 10 of 11LABORATORIOS SERRAL GRUPO FARMACEUTICO SOMAR S.A. DE C.V. PLANTA CHALCO: Camino Real a Cocotan SIN. Esquina Consttuién § de Fetxero, Zona Indurial Chaico Serral NS LOTE: E191197A PRESENTACION: Tabletas DOSIS: 1 mg PROCESO: Transferencia Analitica PRUEBA: Disolucién ___ SAMPLE SET Injection | Processed le Run Tie fogusion | Sarple Servis —sarteTie| va ve fons Vaure | eens eee Ss ln + Bu Uneom [1 | = 1) 600, 10000/FNASTERIDA.DS10m000 WoWse Cha 220m 100000 DL Uneom |? | 2) 600, 10000/FNASTERIDA.DIS10m000 Wass8ChA Zam 100000 STDIADE Sanda (2 | 1] 60010000 FINASTERDA DIS 100000, n499ChAZzonm | 100000 STD1ADE __Sadard [2 | 2| 600] 10000] FINASTERIDA DIS | 1.00000| Wa480CGhA Z2mrm 1.00000 STDTADE_Sandad__(2 | | 600] _10000| FINASTERDA DIS] 1.0000) v9 ChA7Zonm| 100000 ‘STD 1ADE Stndad 2 | 4| 600/ 10000|FINASTERIDADIS 1.00000 Wa289GrA Z20em| 1.00000 ‘STD 1ADE Stender 2 5| 600| 100.00 FINASTERIDA_DIS 1.00000 W2489ChA220nm) 1.00000 SIOIADE Sansa? | -6| 600) 10000 FINASTERIDA DIS 100000/ WoI89GhA Zoom 10000 ‘sTD2 ‘Unknown 3 1 600) 100.00/ FINASTERIDADIS 1.00000 W2489ChA2200m| 1.00000 | 0/sr2 ___(Unieom 13/2] 600] 10000| FINASTERIDA DIS | 1.0000 / Wao CnA20wn| 100000 [H1/EV@HI@7ALDIS_Mi Unipom 41) 600) 10000| FINASTERIDA DIS | 1.00000 wet ChA Zonm s00.0000 [12 E1@tt67~ DIS M2 [Unicom /8 | 1] 40000] FINASTERIDA DIS | 1.000 Woo CrA 220mm | 60000000 18 EIGHS7ADIS M3 Unieom 6 | 40000 | FINASTERIDA.DIS 1.00000) W24@0.ChA 220mm | 60000000 “4 EISHS7ADIS M4 Unioom 7 | {0000 FINASTERIOA.DIS| 100000 Wo8E0 Gx 220m 2000000 | | 1 EIBHI®7ADIS MS Unioom 8 | 1 10000 | FINASTERIDA DIS) 102000 Wa#E0 a 22m) 200000 | 16 EIB4I97ADIS M5) Unioom |e | 1 10000 | FINASTERIDA DIS | 10500, W24#0 Cha 2200n 90000000 a stot Stdord 2 | 10000 |FINASTERIDADIS | 100000 W248@ChA2200m 100000 Report Method Name: Finasterida_Dis Printed 02:21:46 p.m. America/Mexico_City martes, 24 de septiembre de 2019 Page: 11 of 11