retecma:.és- CERTIFICADO DE ANALISIS FAFO.00 Version 1.1.8 PRODUCT: ERYTHROMYCIN BASE Mig date: Dec. 2017 BATCH No: EBS/1712-116 Exp. Date: Nov. 2022 Tests Specifications Results Appearance White or slightly yellow, crystalline powder or colorless or White powder slightly yellow crystals, slightly codoriess or practically odorless, Solubility Slightly soluble in: Water Slightly soluble Freely soluble in Ethanol (96%) Freely soluble Soluble in Methanol Soluble Identification by AR Sample spectra confirms to that of Standard Complies Icentiication 8- TLC Principal spot due to test solution is similar in position, ‘color and size tothe principle peak obtained with Complies reference solution Related Substances by Specified Impurities HPLC Impurity A: NMT 2.0% 0.047% Impurity B: NMT 2.0% 0.84% Impurity C: NMT 3.0% 0.93% Impurity D:NMT 1.0% BRT Impurity E: NMT 1.0% BRT Impurity F: NMT 1.0% Not detected Impurity HINMT 1.0% BRT Impurity L: NMT 0.4% BRT Impurity M: NMT 1.0% BRT Uspecified Impurities ‘Any other impurity: NMT 0.4% BRT Total Impurities: NMT 7.0% 2.24% Reporting Threshold: 0.2% Disregard peak due to Erythromycin 8 and. Erythromycin C Thiccynate content NMT 0.3% 0.08% Water content NMT 6.5% 1.23% Sulfated Ash NTM 0.2% 0.01% Assay by HPLC. ‘Sum of the erythromycin A, B and C; NLT 93.0% and 97.6% NMT 102.0% Erythromycin 8 NMT 5.0% 0.1% Erythromycin NMT 5.0% 02% (on anhydrous substance basis ) Residual Solvents, Dichloromethane NMT 600 ppm Bat. COPIA DEL CERTIFICADO ORIGINAL, SC NS QFBTopye Dionisio Atentamente, Sanehez Cabafas Retecma, S.A. DE C.V. Resp. ARM-408-01 RETECMA ¢ _RePRESENTACIONES EN TECNOLOGIA Y MATERIAS PRIMAS PARA LA INDUSTRIA FARMACEUTICA Ortpulce No.1. Ca Oxtopuco Universe CP. 04318 Meco DF. Apartado Postal 2075, Te +452 55) 5490 700 mutoas Fax +52 (5) 5663329 Gna nfo@reecracommx