Test Specification Min Max ASSAY 98 102.00% IDENTIFICATION TO PASS TEST TO PASS TEST ETHYLBENZENE, CYCLOHEXYLMETHANOL, BENZYL ALCOHOL AND BENZOIC ACID TO PASS TEST TO PASS TEST CHLORINATED COMPOUNDS TO...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 170� 174�C LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTD IDENTIFICATION TO PASS TEST RETEST...
Test Specification Min Max ASSAY (DRIED BASIS) 97 101.50% pH OF A 1 IN 20 SOLUTION 4 5 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS...
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% CHLORIDE CONTENT (DRIED BASIS) 20.2 20.80% LOSS ON DRYING 2.00% RESIDUE ON IGNITION 0.50% ORGANIC IMPURITIES: PYRIDIINE-2-ALDOXIME 0.50% PRALIDOXIME ANTI-ISOMER 2%...
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% COLOR OF SOLUTION TO PASS TEST TO PASS TEST CLARITY OF SOLUTION TO PASS TEST TO PASS TEST pH OF A...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 3.00% RESIDUE ON IGNITION 0.30% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +39� to +45� +39� to +45� WATER DETERMINATION 6.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST LIMIT OF OMEPRAZOLE RELATED COMPOUNDS F AND G 350 PPM LOSS ON...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% FLUOROURACIL RELATED COMPOUND F 0.25% UREA 0.20% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Test Specification Min Max ASSAY (I[@2@]) 99.8 - 100.5 % 99.8 - 100.5 % NONVOLATILE RESIDUE 0.05% CHLORIDE AND BROMIDE (as Cl) 0.03% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST IDENTIFICATION TO...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% 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) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IMIDAZOLE 0.50% CLOTRIMAZOLE RELATED COMPOUND A 0.50%...
Test Specification Min Max LIPASE ACTIVITY 24 U/mg 24 U/mg AMYLASE ACTIVITY 100 U/mg 100 U/mg PROTEASE ACTIVITY 100 U/mg 100 U/mg MICROBIAL LIMITS TO PASS TEST TO PASS TEST...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% ACIDITY OR ALKALINITY TO PASS TEST WATER DETERMINATION 10.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED OXALATE 0.35% RELATED COMPOUNDS 0.50% IDENTIFICATION...
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% IDENTIFICATION TO PASS TEST TO PASS TEST LOSS ON DRYING 1.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +63� to +70� +63� to +70� LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% GUANINE 0.70% WATER DETERMINATION 6.00% ORDINARY IMPURITIES 1% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE...
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0 % 98.0 - 102.0 % CHLORIDE (Cl) 13.52 - 14.20 % 13.52 - 14.20 % CHROMATOGRAPHIC PURITY TO PASS TEST...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% HEAVY METALS 0.00% N,N-DIMETHYLANILINE 0.00% PHENOLIC COMPOUNDS TO PASS TEST IDENTIFICATION TO PASS TEST...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 100.50% WATER DETERMINATION 7 9.00% 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) 98.5 101.50% SPECIFIC ROTATION [a][@D@] -48� to -52� -48� to -52� LOSS ON DRYING 2 4.20% COLOR OF SOLUTION TO PASS TEST TO...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 100.50% WATER DETERMINATION 9 10.00% RESIDUE ON IGNITION 0.10% RESIDUAL TURPENTINE TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO...
Test Specification Min Max ASSAY (DRIED BASIS) 97.5 102.00% SPECIFIC ROTATION [a][@D@] -125 to -134 -125 to -134 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED...
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 152� 156.5� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% CHLORIDE (Cl) 0.10% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL...
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION @ 20 C +158� to +167� +158� to +167� LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ORGANIC IMPURITIES...
Test Specification Min Max ASSAY 97 103.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.30% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS...
Test Specification Min Max ASSAY (DRIED BASIS) 98.00% 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% CHLORIDE (Cl) 0.02% SULFATES (SO[@4@]) 0.02% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS REPORTED LEAD...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% WATER DETERMINATION 8.50% RESIDUE ON IGNITION 0.30% RELATED COMPOUNDS 2.00% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS REPORTED AS REPORTED LEAD (Pb) AS...
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% COMPLETENESS AND COLOR OF SOLUTION TO PASS TEST MELTING RANGE 128� 132�C SPECIFIC ROTATION [a][@D@] -15.7� to-17.3 -15.7� to-17.3 ABSENCE OF...
Test Specification Min Max VISCOSITY OF 1% AQUEOUS SOLUTION @25[dC 2500 7500 cP pH (1%) 6 8.5 LOSS ON DRYING 10.00% RESIDUE ON IGNITION 5.00% LEAD (Pb) 0.00% ELEMENTAL IMPURITIES:...
Test Specification Min Max ASSAY 98 101.00% MELTING RANGE 76� 78�C LOSS ON DRYING (OVER P[@2@]O[@5@]) 1.00% RESIDUE AFTER IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION...
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 90 102.00% WATER DETERMINATION 17.00% ZINC TO PASS TEST TO PASS TEST ACRIFLAVIN TO PASS TEST TO PASS TEST ORGANIC IMPURITIES TO PASS...
Test Specification Min Max ASSAY (C[@27@]H[@44@]O) 97 103.00% SPECIFIC ROTATION [a][@D@] +105 to +112� +105 to +112� ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST CERTIFIED HALAL RETEST DATE DATE...
Test Specification Min Max ASSAY (Na[@2@]S[@2@]O[@3@]; ANHYDROUS BASIS) 99 100.50% WATER DETERMINATION 32 37.00% pH OF A 10% SOLUTION 6 8 CALCIUM (Ca) TO PASS TEST TO PASS TEST HEAVY...