Ivermectin USP Potassium 10% ELEMENTAL IMPURITIES AS REPORTED

10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED EARLY-ELUTING COMPOUNDS TO PASS TEST TO PASS TEST LATE-ELUTING COMPOUNDS TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST

5 % w TRACEABLE TO NIST EXPIRATION DATE

Test Specification Min Max MANGANESE (Mn) 995 - 1005 ppm 995 - 1005 ppm TRACEABLE TO NIST EXPIRATION DATE

Test Specification Min Max APPEARANCE WHITE POWDER WHITE POWDER ASSAY 98% 98%

10% NICKEL 1 ppm REDUCING SUGARS TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED MICROBIAL LIMITS TOTAL AEROBIC MICROBIAL COUNT 1000 cfu/mL 1000 cfu/mL TOTAL COMBINED MOLDS AND YEASTS COUNT 100 cfu/mL 100 cfu/mL IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST

Ivermectin USP Potassium 10% ELEMENTAL IMPURITIES AS REPORTEDTest Specification Min Max ASSAY (Sum of H[@2@]B[@1a@] and H[@2@]B[@1b@]; Dried, Alcohol & 95 102. 00% & Formamide free Basis) RATIO (H[@2@]B[@1a@] H[@2@]B[@1a@] + H[@2@]B[@1b@] 90% SPECIFIC ROTATION 17 to 20 17 to 20 RESIDUE ON IGNITION 0. 10% ELEMENTAL IMPURITIES: RHODIUM (Rh) 1 ppm WATER DETERMINATION 1. 00% ALCOHOL AND FORMAMIDE TO PASS TEST TO PASS TEST RELATED COMPOUNDS TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS TEST