Test Specification Min Max ASSAY (by GC) 98% 98%

Test Specification Min Max ASSAY (by GC) 95%

Test Specification Min Max COMPOSITION TYPICAL TYPICAL BISMUTH 50.00% 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...

Test Specification Min Max APPEARANCE

Test Specification Min Max NO 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...

Test Specification Min Max APPEARANCE

Test Specification Min Max ASSAY APPROX. 97 % APPROX. 97 % RETEST DATE

Test Specification Min Max APPEARANCE EXPIRATION 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...

Test Specification Min Max APPEARANCE

Test Specification Min Max APPEARANCE

Test Specification Min Max EXPIRATION 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...

Test Specification Min Max APPEARANCE

Test Specification Min Max ASSAY 90% 90%

Test Specification Min Max ASSAY APPROX. 99 % APPROX. 99 % EXPIRATION DATE

Test Specification Min Max ASSAY 99%

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...

Test Specification Min Max VISCOSITY, BROOKFIELD, 5% DISPERSION 800 2200 cP

Test Specification Min Max APPEARANCE Reddish amber to Reddish amber to REFRACTIVE INDEX (@ 20�C) 1.515 1.53 SPECIFIC GRAVITY (@ 25�C) 0.983 1.022

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...

Test Specification Min Max CLARITY OF SOLUTION TO PASS TEST TO PASS TEST VISUAL TRANSITION INTERVALS pH 8.8 (clrlss) pH 8.8 (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...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH OF A 2% SOLUTION @ 25�C 6 7.5 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% CHLORIDE (Cl) 0.06% RELATED...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH OF A 1 % SOLUTION @ 25[dC 2.7 3.4 WATER DETERMINATION 5.00% RELATED COMPOUNDS 1.00% RESIDUE ON IGNITION 0.20% ABSORBANCE...

Test Specification Min Max ASSAY 97 102.00% LOSS ON DRYING @ 105 C 0.50% ORGANIC IMPURITIES: . . THEOPHYLLINE RELATED COMPOUND C 0.10% THEOPHYLLINE RELATED COMPOUND B 0.10% THEOPHYLLINE RELATED...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 2.00% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION...