Timolol Maleate USP size:100 GM 5 EU/g MICROBIAL LIMITS TOTAL

5 EU/g MICROBIAL LIMITS TOTAL AEROBIC MICROBIAL COUNT 100 CFU/g TOTAL YEAST AND MOLD COUNT 100 CFU/g ESCHERICHIA COLI Negative SALMONELLA Negative RETEST DATE

95% APPROX

10% HEAVY METALS 30 ppm IDENTIFICATION RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST

543 SOLIDIFICATION POINT 3

Timolol Maleate USP size:100 GM 5 EU/g MICROBIAL LIMITS TOTALTest Specification Min Max ASSAY (DRIED BASIS) 98 102. 00% pH OF A 2% SOLUTION 3. 8 4. 3 LOSS ON DRYING 0. 50% RESIDUE ON IGNITION 0. 10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ENANTIOMERIC PURITY 1. 00% ORGANIC IMPURITIES: . . TIMOLOL RELATED COMPOUND B 0. 40% TIMOLOL RELATED COMPOUND D 0. 40% TIMOLOL RELATED COMPOUND E 0. 40% TIMOLOL RELATED COMPOUND C 0. 40% TIMOLOL RELATED COMPOUND F 0. 40% ANY UNSPECIFIED IMPURITY 0. 10% TOTAL DEGRADATION