Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 199?? 203?? LOSS ON DRYING 0.50% CHROMATOGRAPHIC IMPURITIES (TOTAL) TO PASS TEST RESIDUE ON IGNITION 0.10% IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% MELTING RANGE 190?? 193?? ACIDITY TO PASS TEST CLARITY AND COLOR OF SOLUTION TO PASS TEST LOSS ON DRYING 0.50% RESIDUE...

Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% MELTING RANGE 197??- 200?? 197??- 200?? CLARITY AND COLOR OF SOLUTION TO PASS TEST ACIDITY TO PASS...

Test Specification Min Max ASSAY (C[@10@]H[@10@]N[@4@]O[@2@]S) 98 102.00% CLARITY AND COLOR OF SOLUTION TO PASS TEST ACIDITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES...

TestSpecificationMinMaxASSAY99.00%LOSS ON DRYING0.50%

Test Specification Min Max POTENCY (DRIED BASIS) 650 - 850 ??/mg 650 - 850 ??/mg pH 4.5 - 7.0 4.5 - 7.0 LOSS ON DRYING 5.00% IDENTIFICATION TO PASS TEST...

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxASSAY98%98%

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxASSAYAPPROX. 98 %APPROX. 98 %

Test Specification Min Max ASSAY (DRIED BASIS) 97 101.50% LOSS ON DRYING 1.00% ORGANIC IMPURITIES . . SINGLE IMPURITY 2% TOTAL IMPURITIES 4% RESIDUE ON IGNITION 0.50% CHLORIDE (Cl) 0.01%...

Test Specification Min Max ASSAY (DRIED BASIS) 98.9 101.50% SPECIFIC ROTATION [a][@D@] -33.5 to -37.0??/td> -33.5 to -37.0??/td> pH (1 in 50) 4 6.5 LOSS ON DRYING 0.50% ORGANIC IMPURITIES...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ISOTRETINOIN 5.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION...

Test Specification Min Max ASSAY (DRIED BASIS) 95 103.00% CRYSTALLINITY TO PASS TEST TO PASS TEST pH of a 1 % SUSPENSION 4.5 6.5 LOSS ON DRYING 2.00% RELATED SUBSTANCES...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +167??to +175??/td> +167??to +175??/td> WATER DETERMINATION 1.00% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE ORGANIC IMPURITIES TO PASS TEST ELEMENTAL...

TestSpecificationMinMaxASSAY97%97%

Test Specification Min Max POTENCY (NEOMYCIN; DRIED BASIS) 600 ug/mg pH of a 33mg/ml Solution @ 25 C 5 7.5 LOSS ON DRYING 8.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST MELTING RANGE WITHIN 3?? WITHIN 3?? SPECIFIC ROTATION [a][@D@] +8.8??to +12.0 +8.8??to...