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 (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 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) 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 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 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 (ANHYDROUS BASIS) 97.0 - 102.0 % 97.0 - 102.0 % WATER 5.00% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL...
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 (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 (DRIED BASIS) 97.0 - 102.0 % 97.0 - 102.0 % SPECIFIC ROTATION, [a][@D@]25 +56??to +62??/td> +56??to +62??/td> LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...
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 (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 (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 (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 ASSAY (DRIED BASIS) 98.5 - 101.0 % 98.5 - 101.0 % SPECIFIC ROTATION +324 to +338 +324 to +338 LOSS ON DRYING 0.30% CHROMATOGRAPHIC PURITY TO...
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 (ANHYDROUS, SOLVENT-FREE BASIS) 98.5 101.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED WATER DETERMINATION 5.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION DATE OF...
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 (C[@16@]H[@14@]F[@3@]N[@3@]O[@2@]S) 98 102.00% RESIDUE ON IGNITION 0.10% WATER DETERMINATION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION...
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 ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES TO PASS TEST IDENTIFICATION TO PASS TEST...
Test Specification Min Max ASSAY (C[@19@]H[@24@]N[@2@][-HCl; DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED COMPOUNDS TO PASS TEST IDENTIFICATION TO PASS TEST EXPIRATION...
Test Specification Min Max ASSAY (C[@16@]H[@16@]CIN[@3@]O[@3@]S; DRIED BASIS) 98 101.00% LOSS ON DRYING @ 105 C 3.00% RESIDUE ON IGNITION 0.10% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST IDENTIFICATION...