Glyburide USP Antimalarial APIs Test Specification Min Max APPEARANCE

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

water) TO PASS TEST TO PASS TEST RETEST DATE

00% CARBONYL COMPOUNDS (formaldehyde

5 % COLOR OF A 4% SOLUTION TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS TEST COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST SOLUBILITY IN ALCOHOL TO PASS TEST TO PASS TEST pH OF 3

03% ULTRAVIOLET ABSORBANCE (1 cm cell vs

Glyburide USP Antimalarial APIs Test Specification Min Max APPEARANCETest 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