TestSpecificationMinMaxAPPEARANCEEXPIRATION DATEMANUFACTURE DATE

TestSpecificationMinMaxASSAY90%SPECIFIC GRAVITY @ 20[dC0.806 - 0.8090.806 - 0.809ACIDITY0.02%ALCOHOL CONTENT0.30%WATER0.05%

TestSpecificationMinMaxEXPIRATION DATE

TestSpecificationMinMaxASSAY (OsO[@4@])98.00%CLARITY OF SOLUTIONTO PASS TESTTO PASS TESTIDENTIFICATIONTO PASS TESTTO 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...

TestSpecificationMinMaxAPPEARANCEEXPIRATION DATEMANUFACTURE 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...

TestSpecificationMinMaxREFRACTIVE INDEX @ 20[dC1.549-1.5701.549-1.570SPECIFIC GRAVITY @ 25[dC1.050-1.1351.050-1.135IDENTIFICATIONTO PASS TESTTO 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...

TestSpecificationMinMaxASSAY98.00%

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...

TestSpecificationMinMaxASSAY98CLARITY OF SOLUTIONTO PASS TESTTO 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...

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxAPPEARANCE

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...

TestSpecificationMinMaxAPPEARANCEREDDISH-BROWN PWREDDISH-BROWN PWSOLUBILITYTO PASS TESTTO PASS TESTVISUAL TRANSITION INTERVALSpH8.2 (orange)pH8.2 (orange)

TestSpecificationMinMaxEXPIRATION DATE

TestSpecificationMinMaxASSAY99.00%RESIDUE AFTER EVAPORATION0.01%WATER-SOLUBLE TITRABLE ACID0.0005 meqCHLORIDE (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...

TestSpecificationMinMaxASSAY95.00%COLOR (APHA)10WATER0.05%

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...

TestSpecificationMinMaxSENSITIVITY TO SULFANILAMIDETO PASS TESTTO PASS TESTSOLUBILITYTO PASS TESTTO PASS TESTWATER5%

TestSpecificationMinMaxASSAYAPPROX. 98 %APPROX. 98 %