Test Specification Min Max APPEARANCE EXPIRATION DATE MANUFACTURE DATE

Test Specification Min Max ASSAY 90% SPECIFIC GRAVITY @ 20[dC 0.806 - 0.809 0.806 - 0.809 ACIDITY 0.02% ALCOHOL CONTENT 0.30% WATER 0.05%

Test Specification Min Max EXPIRATION DATE

Test Specification Min Max ASSAY (OsO[@4@]) 98.00% CLARITY OF SOLUTION TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS TEST

Test Specification Min Max ASSAY [ALDEHYDES AS DECYL ALDEHYDE (C[@10@]H[@20@]O] 1.2 - 2.5 % 1.2 - 2.5 % ANGULAR ROTATION +94 to +99 +94 to +99 REFRACTIVE INDEX @ 20[dC...

Test Specification Min Max APPEARANCE EXPIRATION DATE MANUFACTURE DATE

Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0% 98.0 - 102.0% pH OF A 1 % SOLUTION @ 25[dC 5.0 - 7.5 5.0 - 7.5 LOSS ON DRYING...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97.5 102.00% MAGNESIUM (ANHYDROUS BASIS) 3.3 355% WATER 7 10.00% ABSORBANCE @ 440 nm 0.1 RELATED SUBSTANCES TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (C[@18@]H[@19@]N[@3@]O.HCl; AHYDROUS BASIS) 98 102.00% WATER DETERMINATION 9 10.50% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST RESIDUE ON IGNITION 0.10% ONDANSETRON RELATED COMPOUND D...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% pH 4 6.5 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY 95 105.00% SPECIFIC GRAVITY 1.011 1.016 REFRACTIVE INDEX @ 20?? 1.5 1.503 CHROMATOGRAPHIC PURITY TO PASS TEST ACIDITY TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 95.0 - 102.0 % 95.0 - 102.0 % pH OF A 1% SOLUTION 2.3 - 2.9 2.3 - 2.9 SPECIFIC OPTICAL ROTATION -188...

Test Specification Min Max REFRACTIVE INDEX @ 20[dC 1.549-1.570 1.549-1.570 SPECIFIC GRAVITY @ 25[dC 1.050-1.135 1.050-1.135 IDENTIFICATION TO PASS TEST TO PASS TEST

Test Specification Min Max ASSAY (C[@18@]H[@23@]NO??[@6@]H[@8@]O[@7@; DRIED BASIS] 98 101.50% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST ISOMER CONTENT TO PASS TEST ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY 98.00%

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS TEST MELTING RANGE 202?? 208?? SPECIFIC...

Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% LOSS ON DRYING 0.50% SULFATED ASH 0.10% CHLORIDES 500 ppm 2-CHLORO-4-NITROANILINE 100 ppm 5-CHLOROSALICYLIC ACID 60 ppm RELATED SUBSTANCES TO PASS...

Test Specification Min Max ASSAY 98 CLARITY OF SOLUTION TO PASS TEST TO PASS TEST

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 APPEARANCE

Test Specification Min Max APPEARANCE

Test Specification Min Max ASSAY (ANHYDROUS BASIS) as ASCORBIC ACID 73.50% as NIACINAMIDE 24.50% as ASCORBIC ACID + NIACINAMIDE 99.00% MELTING RANGE 141 - 145 C 141 - 145 C...

Test Specification Min Max APPEARANCE REDDISH-BROWN PW REDDISH-BROWN PW SOLUBILITY TO PASS TEST TO PASS TEST VISUAL TRANSITION INTERVALS pH 8.2 (orange) pH 8.2 (orange)

Test Specification Min Max EXPIRATION DATE

Test Specification Min Max ASSAY 99.00% RESIDUE AFTER EVAPORATION 0.01% WATER-SOLUBLE TITRABLE ACID 0.0005 meq CHLORIDE (Cl) 5 ppm

Test Specification Min Max ASSAY (C[@6@]H[@6@]N[@2@]O; DRIED BASIS) 98.5 101.00% MELTING RANGE 128?? 131?? LEAD (Pb) 2 mg/kg LOSS ON DRYING 0.50% READILY CARBONIZABLE SUBSTANCES TO PASS TEST RESIDUE ON...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% COMPLETENESS OF SOLUTION TO PASS TEST SPECIFIC ROTATION [a][@D@] -187??to -197??/td> -187??to -197??/td> CHLORIDE (Cl) 9.2 9.58% WATER DETERMINATION AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% SPECIFIC ROTATION [a][@D@] -170??to -181??/td> -170??to -181??/td> CHLORIDE CONTENT (DRIED BASIS) 9.54 9.94% NOROXYMORPHONE HCl AND OTHER[nIMPURITIES TO PASS TEST LOSS...

Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0% 98.0 - 102.0% MELTING RANGE 171 - 176 C (dec 171 - 176 C (dec LOSS ON DRYING 2.00% RESIDUE...

Test Specification Min Max ANGULAR ROTATION +8 to +30 +8 to +30 REFRACTIVE INDEX @ 20[dC 1.474- 1.488 1.474- 1.488 SOLUBILITY IN ALCOHOL TO PASS TEST TO PASS TEST SPECIFIC...

Test Specification Min Max ASSAY 95.00% COLOR (APHA) 10 WATER 0.05%

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION +83.0 to+89.5??/td> +83.0 to+89.5??/td> CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES: NICKEL...

Test Specification Min Max SENSITIVITY TO SULFANILAMIDE TO PASS TEST TO PASS TEST SOLUBILITY TO PASS TEST TO PASS TEST WATER 5%

Test Specification Min Max ASSAY APPROX. 98 % APPROX. 98 %