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...
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION +22.4 to+24.7??/td> +22.4 to+24.7??/td> pH (1 IN 100) 5.6 6.1 LOSS ON DRYING 0.30% RELATED COMPOUNDS TO PASS TEST...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% RELATED COMPOUNDS TO PASS TEST ENANTIOMERIC PURITY TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED WATER...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 3 9.00% CHLORIDE 0.05% SULFATE 0.20% LEAD 10 ppm HEAVY METALS 20 ppm REDUCING SUBSTANCES 1.00% IDENTIFICATION TO PASS...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS...
Test Specification Min Max MELTING RANGE 38?? 44?? IODINE VALUE 18 36 ACID VALUE TO PASS TEST TO PASS TEST ALKALINITY TO PASS TEST TO PASS TEST WATER DETERMINATION 0.25%...
Test Specification Min Max CLARITY AND COLOR OF SOLUTION TO PASS TEST SPECIFIC ROTATION [a][@D@] +54.4 to+55.9 +54.4 to+55.9 ACIDITY / ALKALINITY TO PASS TEST WATER DETERMINATION 4.5 5.50% MICROBIAL...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% ETHYNYL GROUP 7.81 8.18% MELTING RANGE (WITHIN 4??) 232?? 239?? SPECIFIC ROTATION, [a][@D@]25 -30??to -35??/td> -30??to -35??/td> RESIDUE ON IGNITION 0.30%...
Test Specification Min Max ASSAY 790 ug/mg 790 ug/mg SPECIFIC ROTATION [a][@D@] +135 to +150 +135 to +150 CRYSTALLINITY TO PASS TEST TO PASS TEST pH OF A 1 IN...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@] +20.4 to +21.4??/td> +20.4 to +21.4??/td> CHLORIDE CONTENT 19 19.60% RELATED COMPOUNDS TO PASS TEST TO PASS TEST...
Test Specification Min Max ASSAY (DRIED BASIS) 98.0-102.0 % 98.0-102.0 % SPECIFIC ROTATION [a][@D@] +8.4 to +9.9 +8.4 to +9.9 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON...
Test Specification Min Max ASSAY (C[@21@]H[@31@]N[@3@]O[@5@]; ANHYDROUS BASIS) 98 102.00% SPECIFIC ROTATION -115.3 to -122.5 -115.3 to -122.5 WATER DETERMINATION 8 9.50% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@]20 +20.4 to +21.4??/td> +20.4 to +21.4??/td> CHLORIDE CONTENT 19 19.60% RELATED COMPOUNDS TO PASS TEST TO PASS TEST...
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 92 97.0?? SPECIFIC ROTATION [a][@D@] +1 to -1??/td> +1 to -1??/td> LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS...
Test Specification Min Max IODINE (I) 4.5- 5.5 g/100 m 4.5- 5.5 g/100 m POTASSIUM IODIDE (KI) 9.5-10.5 g/100 m 9.5-10.5 g/100 m ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION...
Test Specification Min Max ALCOHOL DETERMINATION 44 50.00% IODINE 1.8 2.2 g/100ml SODIUM IODIDE (NaI) 2.1 2.6 g/100ml ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS...