Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% RELATED SUBSTANCES TO PASS TEST TO PASS TEST CHLORIDE (Cl) 100 ppm LOSS ON DRYING 0.50% SULPHATED ASH 0.10% ELEMENTAL IMPURITIES:...

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 (ANHYDROUS BASIS) 97 103.00% SPECIFIC ROTATION -5� to -6� -5� to -6� WATER DETERMINATION 11.00% ORGANIC IMPURITIES, PROCEDURE 2 . . LIOTHYRONINE 1.00% MONOCHLOROTRIIODOTHYRONINE 0.15%...

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 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) 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 (DRIED BASIS) 98 102.00% MELTING RANGE 117� 120�C LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS...

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 (SO[@2@]) 58.5 67.40% IRON (Fe) 0.01% LEAD (Pb) 2 mg/kg SELENIUM (Se) 5 mg/kg IDENTIFICATION (A) POSITIVE POSITIVE IDENTIFICATION (B) POSITIVE POSITIVE EXPIRATION DATE MANUFACTURE...

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 (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 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 (ANHYDROUS BASIS) 98 102.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST WATER DETERMINATION 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

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...