Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@] -32.7??to-34.7 -32.7??to-34.7 pH OF A 1 IN 100 SOLUTION 5.4 6 LOSS ON DRYING 0.30% RESIDUE ON IGNITION...

Test Specification Min Max CONGEALING RANGE 47?? 65?? ACIDITY TO PASS TEST TO PASS TEST ALKALINITY TO PASS TEST TO PASS TEST READILY CARBONIZABLE SUBSTANCES TO PASS TEST TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% SULFATE 0.20% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 146?? 150?? LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION A (IR) TO PASS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 8-BROMOTHEOPHYLLINE 72.2 76.60% 2-AMINO-2-METHYL-1-PROPANOL 24.6 26.40% WATER DETERMINATION 3% THEOPHYLLINE[n(C[@7@]H[@8@]N[@4@]O[@2@]) 0.50% HEAVY METALS 20 ug/g IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 101.00% MELTING RANGE 188 191?? WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST...

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

Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 102.0 % 97.0 - 102.0 % LOSS ON DRYING 1.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 99.5 100.50% LOSS ON DRYING 0.50% INSOLUBLE SUBSTANCES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS REPORTED MERCURY...

Test Specification Min Max ASSAY (K[@2@]S[@2@]O[@5@] as SO[@2@]) 51.8 57.60% IRON (Fe) 10 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST CERTIFIED KOSHER CERTIFIED...

Test Specification Min Max SPECIFIC GRAVITY @ 25[dC 1.017 1.02 REFRACTIVE INDEX @ 20[dC 1.531 1.534 RESIDUE ON IGNITION 0.01% CHLORINATED COMPOUNDS (as Cl) TO PASS TEST ALDEHYDE TO PASS...

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 (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 (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 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 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) 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 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 (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 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 (ANHYDROUS BASIS) 97 103.00% IDENTIFICATION TO PASS TEST TO PASS TEST WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED EXPIRATION...

Test Specification Min Max ASSAY (Mg) 14.5 16.40% pH (in 50 mg/ml SUSPENSION) 5 9 LOSS ON DRYING 2.00% CHLORIDE (Cl) 0.05% SULFATE 0.20% ARSENIC (As) 3 ppm ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY (C[@26@]H[@33@]NaO[@8@]; DRIED BASIS) 97 103.00% SPECIFIC ROTATION +96??to +104??/td> +96??to +104??/td> SODIUM (DRIED BASIS) 4.49 4.77% LOSS ON DRYING 3.00% IDENTIFICATION TO PASS TEST TO...