TestSpecificationMinMaxASSAY (ANHYDROUS, SOLVENT-FREE BASIS)97.5101.50%RESIDUE ON IGNITION0.10%HEAVY METALS10 ug/gRELATED COMPOUNDSTO PASS TESTTO PASS TESTWATER DETERMINATION1.00%

TestSpecificationMinMaxMELTING POINT215??219??SOLUBILITYTO PASS TESTTO PASS TEST

TestSpecificationMinMaxPOTENCY750 ug/mg LOSS ON DRYING5.00%RESIDUE ON IGNITION3.00%AMPHOTERICIN A15%IDENTIFICATIONTO PASS TESTRETEST DATERESIDUAL SOLVENTS

Test Specification Min Max ASSAY (C[@28@]H[@37@]ClO[@7@] 97 102.00% SPECIFIC ROTATION, [a][@D@]25 +21??to +25??/td> +21??to +25??/td> LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST RESIDUE ON IGNITION...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 900 1050 ??/mg CRYSTALLINITY TO PASS TEST pH OF A 0.2% SOLUTION 3.5 6 WATER DETERMINATION 11.5 14.50% DIMETHYL ANILINE TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST pH 3.2 3.8 RELATED SUBSTANCES TO PASS TEST TO PASS TEST IMPURITY...

Test Specification Min Max ASSAY (C[@11@]H[@12@]Cl[@2@]N[@2@]O[@5@]) 555 - 595 ??/mg 555 - 595 ??/mg MELTING RANGE 87??- 95?? 87??- 95?? SPECIFIC ROTATION, [a] (C=5;ANHYD. ALCOHOL) +21??to +25??/td> +21??to +25??/td> CRYSTALLINITY...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST ACIDITY TO PASS TEST TO PASS TEST SULFATHIAZOLE AND OTHER PRIMARY AROMATIC...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION @25 C -43??to -47??/td> -43??to -47??/td> LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% SULFATE 0.20% ELEMENTAL IMPURITIES AS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% BROMIDE (Br) 17.5 18.20% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 900 - 1050 ug/mg 900 - 1050 ug/mg CRYSTALLINITY TO PASS TEST DIMETHYLANILINE TO PASS TEST pH (1% SOLUTION) 3.5 - 6.0 3.5...