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...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 101.50% SAPONIFICATION VALUE 142.2 146 WATER DETERMINATION 5.00% LEAD (Pb) 10 ppm SODIUM STEARYL MALEATE AND STEARYL ALCOHOL TO PASS TEST ELEMENTAL...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.05% CHLORIDE (Cl) 0.01% SULFATES (SO[@4@]) 0.02% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.05% CHLORIDE (Cl) 0.01% SULFATES (SO[@4@]) 0.02% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC...