TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxAPPEARANCEWHITE TO OFF-WHIWHITE TO OFF-WHIASSAYAPPROX. 97 %APPROX. 97 %WATER0.50%

TestSpecificationMinMaxASSAY [C[@5@]H[@9@N[@3@]�(H[@3@]PO[@4@])[@2@]]97.50%97.50%HEAVY METALS10 ppmEXPIRATION DATE

TestSpecificationMinMaxASSAYAPPROX. 96 %APPROX. 96 %

TestSpecificationMinMaxAPPEARANCEWHITE POWDERWHITE POWDER

TestSpecificationMinMaxASSAY99%MELTING POINT182�- 188�C182�- 188�CpKa @ 25 C8.1 - 8.28.1 - 8.2EXPIRATION DATE

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 (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@] +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) 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% 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 (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) 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...

TestSpecificationMinMaxABSORPTION MAX. (IN METHANOL)607 nmEXPIRATION DATE

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 (DRIED BASIS) 97 103.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES: NICKEL (Ni) AS REPORTED AS REPORTED MOLYBDENUM (Mo) AS REPORTED AS...

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...

TestSpecificationMinMaxASSAY95%EXPIRATION DATE

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 (C[@5@]H[@11@]NO[@2@]S; DRIED BASIS) 98.5 101.50% LEAD (Pb) 5 mg/kg LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% IDENTIFICATION PASSES TEST EXPIRATION DATE DATE OF MANUFACTURE...