Hydrocortisone Micronized USP Chiral Compounds Test Specification Min Max HYDROXYL

Test Specification Min Max HYDROXYL VALUE 154 162 SAPONIFICATION VALUE 176 182 ALKALINE IMPURITY TO PASS TEST TO PASS TEST TRIGLYCERIDE COMPOSITION TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED NICKEL 20 ug/g IODINE VALUE 5 ACID VALUE 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

Test Specification Min Max LOSS ON DRYING @ 105 C 0

Test Specification Min Max VISUAL TRANSITION INTERVALS pH 10

Test Specification Min Max ABSORPTION MAX 660 (395) nm 660 (395) nm

[a][@D@]25 -0

Hydrocortisone Micronized USP Chiral Compounds Test Specification Min Max HYDROXYLTest Specification Min Max ASSAY (DRIED BASIS) 97 102. 00% SPECIFIC ROTATION [a]D25 +150 to +156 +150 to +156 PARTICLE SIZE (THROUGH 15 micron) 90% LOSS ON DRYING 1. 00% RESIDUE ON IGNITION 0. 50% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST