Fludrocortisone Acetate Micronized USP Instrument Check Verification Test Specification Min Max BISMUTH

Test Specification Min Max BISMUTH 995 - 1005 ppm 995 - 1005 ppm STANDARDIZED AGAINST NIST 3106 3106 EXPIRATION DATE

2 % 10 % +/-0

20% 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

00% RETEST DATE

941 APPEARANCE Colorless to pal Colorless to pal

Fludrocortisone Acetate Micronized USP Instrument Check Verification Test Specification Min Max BISMUTHTest Specification Min Max ASSAY (DRIED BASIS) 97 103. 00% SPECIFIC ROTATION [a][@D@] 126?? 138?? td> CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 3. 00% RESIDUE ON IGNITION 0. 10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST