Test Specification Min Max ASSAY (ANHYDROUS BASIS) 96 102.00% SPECIFIC ROTATION (20�C) -94� to -102� -94� to -102� CRYSTALLINITY TO PASS TEST TO PASS TEST pH 8 10 WATER DETERMINATION...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH OF A 1 IN 40 SOLUTION 3 4.5 WATER DETERMINATION 4.7 6.70% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 101.0% 99.0 - 101.0% MELTING RANGE 194� - 199�C 194� - 199�C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% SELENIUM...

Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% CLARITY OF SOLUTION TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST TO PASS TEST...

Test Specification Min Max ACIDTY (pH OF 2% IN WATER) 5 - 6.5 5 - 6.5 APPEARANCE WHITE OR SLIGHTL WHITE OR SLIGHTL ASSAY 99 - 101 % 99 -...

Test Specification Min Max ASSAY 97.5 102.50% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES DETECTED AT (UV 240 nm): Bispirone related compound...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 139 144�C LOSS ON DRYING 1.00% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED...

TestSpecificationMinMaxASSAY (C[@6@]H[@9@]N[@3@]O[@3@])99101.00%MELTING RANGE159�162�CRELATED SUBSTANCESTO PASS TESTLOSS ON DRYING0.50%SULFATED ASH0.10%

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) 98 102.00% WATER DETERMINATION 5.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST...

Test Specification Min Max EXCHANGE CAPACITY 1.8 2.2 g pH OF A 1 IN 100 SLURRY 4 6 CHLORIDE CONTENT 13 17.00% LOSS ON DRYING 12.00% RESIDUE ON IGNITION 0.10%...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.0 % 98.5 - 101.0 % pH OF A 5% SOLUTION 3.5 - 5.5 3.5 - 5.5 LOSS ON DRYING 0.50%...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 0.50% 3-CHLOROBENZOIC ACID TO PASS TEST TO PASS TEST ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% MELTING RANGE 136 141 C LOSS ON DRYING 0.50% ORDINARY IMPURITIES 2.00% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION (A) SPECTRUM SPECTRUM IDENTIFICATION...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% MELTING RANGE APPROX. 196�C APPROX. 196�C SPECIFIC ROTATION [a][@D@] +98� to +104� +98� to +104� LOSS ON DRYING 2.00% ORGANIC IMPURITIES...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% PLATINUM CONTENT (ANHYDROUS BASIS) 64.42 65.22% CRYSTALLINITY TO PASS TEST UV PURITY RATIO 4.5 WATER DETERMINATION 1.00% TRICHLOROAMMINEPLATINATE 1.00% TRANSPLATIN 2.00%...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH OF A 2% SOLUTION 6.5 8 WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED EARLY-ELUTING...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +97� to +105� +97� to +105� LOSS ON DRYING 1.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +45� to +51� +45� to +51� LOSS ON DRYING 1.00% MEDROXYPROGESTRONE ACETATE[nRELATED COMPOUND A 0.50% ORGANIC IMPURITIES TO...

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) 98 102.00% SPECIFIC ROTATION, [a][@D@]20 -41.0� to -43.5 -41.0� to -43.5 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES: LEAD (Pb)...

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 (C[@14@]H[@10@]Cl[@2@]NNaO[@2@]; ANHYDROUS BASIS) 97 103.00% WATER DETERMINATION 4.8 5.80% COPPER 0.00% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a][@D@] -1 to +1 -1 to +1 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED...

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 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...