Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]25 +18.2 to+19.4� +18.2 to+19.4� COLOR OF A 10% SOLUTION TO PASS TEST LOSS ON DRYING 0.10% ORGANIC IMPURITIES...

TestSpecificationMinMaxASSAY (C[@5@]H[@4@]N[@4@]O[@2@])98.00%98.00%RETEST DATE

TestSpecificationMinMaxABSORPTION MAX424 nm

TestSpecificationMinMaxASSAY (by GC)98%98%

TestSpecificationMinMaxASSAY (by GC)95%

TestSpecificationMinMaxCOMPOSITIONTYPICALTYPICALBISMUTH50.00%50.00%LEAD (Pb)25.00%25.00%CADMIUM (Cd)12.50%12.50%TIN (Sn)12.50%12.50%

Test Specification Min Max APPEARANCE PALE YELLOW TO D PALE YELLOW TO D SPECIFIC GRAVITY @ 25�C 0.900 - 0.927 0.900 - 0.927 REFRACTIVE INDEX @ 20�C 1.451 - 1.472...

Test Specification Min Max ASSAY (USP) 98 102.00% ASSAY (JP) 99.00% MELTING POINT (JP) 132.5 134.5�C RESIDUE ON IGNITION 0.10% ALCOHOL-INSOLUBLE MATTER 0.04% CHLORIDE 0.01% SULFATE 0.01% ELEMENTAL IMPURITIES AS...

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxNO SPECIFICATIONS

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST WATER DETERMINATION 0.20% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% MELTING RANGE 200 205�C SPECIFIC ROTATION [a][@D@] +57� to +62� +57� to +62� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...

Test Specification Min Max APPEARANCE COLORLESS,TRANSP COLORLESS,TRANSP ODOR ODORLESS ODORLESS ASSAY ([(NH[@2@])[@2@]CO]) 99.0 - 100.5% 99.0 - 100.5% MELTING POINT 132� - 134�C 132� - 134�C SOLUBILITY IN WATER 1...

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxASSAYAPPROX. 97 %APPROX. 97 %RETEST DATE

TestSpecificationMinMaxAPPEARANCEEXPIRATION DATE

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH OF A 5% SOLUTION 4.5 6.5 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO...

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxEXPIRATION DATE

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % SPECIFIC ROTATION [a][@D@] +26.6 to+28.8 +26.6 to+28.8 pH OF A 5% SOLUTION 5.5 7 RELATED...

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxASSAY90%90%

TestSpecificationMinMaxASSAYAPPROX. 99 %APPROX. 99 %EXPIRATION DATE

TestSpecificationMinMaxASSAY99%

Test Specification Min Max Activity (C[@20@]H[@30@]O) 95.0 % of labele 95.0 % of labele ABSORBANCE RATIO 0.85 ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST...

TestSpecificationMinMaxVISCOSITY, BROOKFIELD, 5% DISPERSION8002200 cP

TestSpecificationMinMaxAPPEARANCEReddish amber toReddish amber toREFRACTIVE INDEX (@ 20�C)1.5151.53SPECIFIC GRAVITY (@ 25�C)0.9831.022

Test Specification Min Max LEVOTHYROXINE 102.-125.4mcg/gr 102.-125.4mcg/gr LIOTHYRONINE 24.3-29.7 mcg/gr 24.3-29.7 mcg/gr MICROBIAL LIMITS TO PASS TEST LOSS ON DRYING 6.00% INORGANIC IODIDES 0.01% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

TestSpecificationMinMaxCLARITY OF SOLUTIONTO PASS TESTTO PASS TESTVISUAL TRANSITION INTERVALSpH8.8 (clrlss)pH8.8 (clrlss)

Test Specification Min Max CLARITY OF SOLUTION TO PASS TEST TO PASS TEST VISUAL TRANSITION INTERVAL(ACID RANGE) pH 1.2 (pink) to pH 1.2 (pink) to VISUAL TRANSITION INTERVAL (ALK.,RANGE) pH...