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...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST IMPURITY F TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50%...
Test Specification Min Max ASSAY 98 100.50% SPECIFIC GRAVITY @ 25[dC 1.013 1.016 DISTILLING RANGE (95 %) 167?? 173?? RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION...
Test Specification Min Max SPECIFIC GRAVITY @ 25[dC 0.818 0.88 VISCOSITY @40.0 C 3 34.4 mm??s ACIDITY TO PASS TEST TO PASS TEST READILY CARBONIZABLE SUBSTANCES TO PASS TEST TO...