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Test Specification Min Max ASSAY (NaI) 99
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
4150 - 14190 1
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 Test Specification Min Max ASSAYTest 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
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