Glyburide USP Antimalarial APIs Test Specification Min Max CALCIUM

Test Specification Min Max CALCIUM (Ca) 6000 ppm 6000 ppm IRON (Fe) 5000 ppm 5000 ppm MAGNESIUM (Mg) 3000 ppm 3000 ppm ALUMINUM 1200 ppm 1200 ppm SODIUM (Na) 1000 ppm 1000 ppm EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE

Test Specification Min Max ASSAY (by HPLC) 98% MELTING RANGE 198 - 202 C 198 - 202 C LOSS ON DRYING 1

50% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST RESIDUE ON IGNITION 0

Test Specification Min Max APPEARANCE DARK-RED POWDER DARK-RED POWDER PARTICLE SIZE 40 - 80 mesh 40 - 80 mesh MOISTURE 10% MICROBIAL LIMITS: TOTAL PLATE COUNT 10

50% WATER 7

Glyburide USP Antimalarial APIs Test Specification Min Max CALCIUMTest Specification Min Max ASSAY (DRIED BASIS) 98. 0 102. 0 % 98. 0 102. 0 % CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1. 00% RESIDUE ON IGNITION 0. 50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS: TO PASS TEST TO PASS TEST