Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 101.00% ALKALINITY TO PASS TEST TO PASS TEST WATER DETERMINATION 1.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO...

Test Specification Min Max ACTUAL VISCOSITY OF 4 % SOLUTION @ 20 C VISCOSITY METHOD USED AS REPORTED AS REPORTED pH OF A 4% SOLUTION 5.0 - 8.0 5.0 -...

Test Specification Min Max ASSAY (OXYETHYLENE, ANHYDROUS BASIS) 70 74.00% HYDROXYL VALUE 96 108 LAURIC ACID 15 17 g/100g SAPONIFICATION VALUE 40 50 ACID VALUE 2 1,4-DIOXANE 10 mg/kg LEAD...

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 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 (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 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 (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 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 (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 (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 ASSAY (C[@4@]H[@6@]O[@5@]) 99.0 - 100.5 % 99.0 - 100.5 % OPTICAL ROTATION -0.10 to+0.10 -0.10 to+0.10 FUMARIC ACID 1.00% LEAD (Pb) 2 mg/kg MALEIC ACID 0.05%...

Test Specification Min Max ASSAY (MgSO[@4@]; ANHYDROUS BASIS) 99 100.50% pH OF A 5% SOLUTION @ 25[dC 5 9.2 LOSS ON IGNITION 48 52.00% APPEARANCE OF SOLUTION TO PASS TEST...

Test Specification Min Max ASSAY 98 103.00% MAGNESIUM CONTENT 6.3 6.70% WATER DETERMINATION 17.5 21.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION...

Test Specification Min Max ASSAY 96 100.50% BULK DENSITY 0.25 0.5 g/cc LOSS ON IGNITION 10.00% FREE ALKALI & SOLUBLE SALTS TO PASS TEST TO PASS TEST ACID-INSOLUBLE SUBSTANCES 0.10%...

Test Specification Min Max ASSAY (MgCl[@2@][-6H[@2@]O) 99.0 - 105.0 % 99.0 - 105.0 % AMMONIUM (NH[@4@]) 0.01% LEAD (Pb) 4 mg/kg SULFATE 0.03% IDENTIFICATION TO PASS TEST EXPIRATION DATE

Test Specification Min Max ASSAY 98 102.00% SOLUBILITY IN 70% ALCOHOL TO PASS TEST TO PASS TEST SPECIFIC GRAVITY @ 25[d/25[dC 1.18 1.185 ANGULAR ROTATION OPTICALLY INACTI OPTICALLY INACTI DIMETHYL...

Test Specification Min Max ASSAY 99.50% ACIDITY TO PASS TEST TO PASS TEST ALKALINITY (AS AMMONIA) 3 ppm WATER DETERMINATION 0.10% NONVOLATILE RESIDUE 0.001 %(w/w) READILY CARBONIZABLE SUBSTANCES TO PASS...

Test Specification Min Max ASSAY, DRIED BASIS (METHOXY GROUPS: -OCH[@3@]) 26 33.00% pH 5 8 VISCOSITY 3000 5600 cP ELEMENTAL IMPURITIES: CHROMIUM (Cr) AS REPORTED NICKEL (Ni) AS REPORTED LOSS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% 2,6-DIMETHYLANILINE 20 ppm ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES TO PASS TEST...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% WATER DETERMINATION 4.5 6.00% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES: N-ACETYLMETOCLOPRAMIDE ( METOCLOPRAMIDE RELATED CPD. A ) 0.15% METHYL 4-ACETAMIDO-2-METHOXYBENZOATE (...

Test Specification Min Max ASSAY 98 102.00% CONGEALING RANGE (A) 27?? 28?? CONGEALING RANGE (B) 30.5??- 32.0?? 30.5??- 32.0?? SPECIFIC ROTATION, [a][@D@]25 -2??to +2??/td> -2??to +2??/td> NONVOLATILE RESIDUE 0.05% RELATED...

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...

Test Specification Min Max ASSAY (C[@3@]H[@7@]MnO[@6@]P; DRIED BASIS) 98 100.50% LEAD (Pb) 4 mg/kg LOSS ON DRYING 12.00% IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE...