MpdiS/0z & Integral Pharma preductos que Genera Bienostar México, D-F., a 04 de Agosto de 2015, ARLEX DE MEXICO S.A. DE C.V. Puerto Veracriiz No. 37 Col. Piloto CP 01200 Deleg. Alvaro Obregén México, D.F. ATN ING. MARTIN ROMERO Por medio de este conducto tenemos el agrado de saludarle y adjuntar a la presente la muestra que a continuacién se detalla: proouero | car wore | 4040007] saamcanre | once | Iraconazl Pets poo 620 Sax a | nazeipetes | 15g 0512 | sep2ore | ‘Asi mismo estamos adjuntando el respectivo certificado analltico emitido por Integral Pharma y por el fabricante del lote arriba mencionado para su respectivo andlisis. ‘Sin mas por el momento agradecemos su atencién a la presente y nos reiteramos @ sus érdenes. Atentamente, ork Lilian Manzano Hernandez Gerente comercial ‘Oficina: iglesia No, 2 Tore "E" Deep. 808 Cal Tzapén San Angel CP. 01080 Wade. F AlmactriDemicilo Fiscal: Francisco César Morales Mz 122117, Col. Sana Martha Acta México DF. 09510, México Tel./Fax #2 (55) 5502850 y $550345, malt nfmintegrabphamaccom | worwintegral-pharma.comMPDISIOZ, Integral heen Productos que Generan Bienestar CERTIFICADO DE ANALISIS Freda TIRACONAZOLE PELLETS 220% Batch Nomar za Page Nanber_[ FageTaPT ‘Manufacturing Date ‘October 2012 A.R. Number _ | 1P22,0/121620009 | Batch Quanta 2000 Ke Expiry Date —[Sepcnier 2016 | =i |e Tans - if wit to cream cor Desrpton Of wie oc Mes he eurement The Retion tn oie The Retatlon Ge of Se SGC principle peak obtained with | peak obtained with tee solution | ‘est solution should match with | matches with that of the Retention eee ‘that ofthe Retention time of | time of principle peak obtained with | Genticalon HPLC) | risine pe ovine’ with | andrdsoluion In he te standard solution inthe test for | Chromatographie purity by HPLC Chromatographic purity by HPLC Water content (by KF, % ww, deermined on 1.b.gm | Not more than 2.0 148 grinded pees) ‘Wot ess than 070 nd wot Bulk Density Ger/mi) more thin 0.85 eae ‘Dissoiin i 900 al FOUN ‘Hydrochloric acid, pH 12 in | Not less than 80 | erat {60 minutes (oy UV, $6 why) « ; (hy HPLC I area normalization method) Todividual impurity | Not more thn 0.5 023 “Total impurity | Not more than 1.25, 049 “Assay Cy OT, % wiv) Each gram offraconazole | Notless than 209 and not | 29.95 pellets should contain ‘more than 23.1 Itraconazole Size of pellet Swi) ‘Retains on ASTM 16 # Mesh | Not more than 10 241 _ssnson ASTM 20 # Mesh | Notes than 80 95.54 te results COMPLY with the requirements of INHOUSE 5 er Preserve in well closed containers at 232°C, excursion between 13 and 30°C Analysis Data as received from our supplier RESPONSABLE SANITARIO L.Q.L GABRIELA A. GOMEZ MELO CEDULA: 4141004 (Oficinas:Ilesia No, Tore “E" Desp. 903 Col. Taapn San Angel CP 01080 Mésien DF ‘AlmaceDomiito Fiscal Fransisco Cir Morales Mz, 22:11. 7 Sona Math Acta 09510, DLP, México “Tel./Fax #32 (55) 53503850 y 33303455 ‘wirwintgalpharna commHPDIS10z Smilax fT CERTIFICATE OF ANALYSIS Product ITRACONAZOLE PELLETS. 22.0% 1P22.0/160000912 Page Number | Page lof ‘October 2012 ‘AR. Number _|1P22.0/121620005 200.0 Ke ‘Expiry Date _ | September 2016 = Specification = Rel Off white to cream color ; heii Meets the requirement The Retention ime oftie | The Retention Gime of the pacipie principle peak obtained with | peak obtained with test solutton testsoluon should match with | matches with that of the Retctin | stat tat of the Retention time of | time of principle peak obtained with ‘Bensication by HPLC) | le pak Soe Standard solution in the test for Standard solution inthe test for | Chromatographie purity by HPLC ic purity by HPLC Water content (By KF, % whn, determined on 1.0 gm — | Notmore than 2.0 1a grinded pellets) | : ‘Not less than 070 and nat / Bulk Density (gm/nl) ee 0.22 | Dissohition in 500 ml FON Hydrochloric acid, pH 1.2in | Not less then 80 8721 60 minutes (by UV. $6,0hu) (Chromatographic parity (by HPLC S% area normalization method ) Individual impurity | Not more than 0.5 023 ‘Total impurity | Not more than 1.25 049 “Assay Coy UV ¥6 wh) Each gram ofliraconazole | Not les than 20.9 and not | 39.95 pellets should contain ‘more than 23.1 Itraconazole Size of pelle 6 why Retains on ASTM 16 # Mesh | Not more than 10 241 Retains on ASTM 20 # Mesh | Not Jess than 90 95.54 Report: The results COMPLY with the requirements of INHOUSE specification Storage condition: Preserve in well closed containers at 232°C, excursion betwgen.{5 and 30°C [ Prepared By ‘Checked By | Ga Syeslros Ue Sloclias ‘Works: Plot No.44, CIE, Gandhi Nagar, Balanagar, Hyderabad 3000