Methylprednisolone Micronized USP Combinatorial Chemistry Test Specification Min Max ASSAY

Test Specification Min Max ASSAY (HPLC) 99%

80% COLOR (APHA) 15 ULTRAVIOLET ABSORBANCE (1 cm cell vs

10% WATER-SOLUBLE ACIDS AND ALKALIES TO PASS TEST TO PASS TEST WATER-SOLUBLE OXIDIZABLE SUBSTANCES TO PASS TEST TO PASS TEST CHLORIDE (Cl) 0

Test Specification Min Max ASSAY 31 - 35 % 31 - 35 % APPEARANCE LIGHT TO DARK LIGHT TO DARK

01% THIOPHENE TO PASS TEST RETEST DATE

Methylprednisolone Micronized USP Combinatorial Chemistry Test Specification Min Max ASSAYTest Specification Min Max ASSAY (DRIED BASIS) 97 103. 00% SPECIFIC ROTATION [a][@D@] +79 to +86 +79 to +86 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1. 00% RESIDUE ON IGNITION 0. 20% ELEMENTAL IMPURITIES: CHROMIUM (Cr) AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST