TestSpecificationMinMaxAPPEARANCERETEST DATE

Test Specification Min Max MELTING RANGE 62 65�C SAPONIFICATION CLOUD TEST TO PASS TEST TO PASS TEST FATS OR FATTY ACIDS, JAPAN WAX,[nROSIN AND SOAP TO PASS TEST TO PASS...

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 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 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 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...

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...

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 ASSAY (PHENOLS) 40% ANGULAR ROTATION -3� to -0.1� -3� to -0.1� REFRACTIVE INDEX @ 20[dC 1.495 - 1.505 1.495 - 1.505 SOLUBILITY IN ALCOHOL TO PASS...

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...

TestSpecificationMinMaxAPPEARANCE

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...

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxASSAY99%99%

Test Specification Min Max ASSAY 99.0 - 100.5 % 99.0 - 100.5 % ALCOHOL-INSOLUBLE MATTER 0.04% CHLORIDE (Cl) 0.01% LEAD (Pb) 5 mg/kg LOSS ON DRYING 1.00% RESIDUE ON IGNITION...

Test Specification Min Max BOTANICAL CHARACTERISTICS TO PASS TEST TO PASS TEST KARAYA GUM TO PASS TEST TO PASS TEST LEAD (Pb) 10 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 102.0 % 97.0 - 102.0 % SPECIFIC ROTATION [a][@D@] +65 to +72 +65 to +72 LOSS ON DRYING 2.00% RESIDUE ON...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 110� - 113�C 110� - 113�C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS...

Test Specification Min Max ACID VALUE 112 168 SAPONIFICATION VALUE 154 220 ROSIN, ROSIN OIL AND COPAIBA TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION...

TestSpecificationMinMaxASSAY97.0 - 103.0%97.0 - 103.0%APPEARANCEWHITE OR ALMOSTWHITE OR ALMOSTWATER (by K-F)0.50%

TestSpecificationMinMaxAPPEARANCE

TestSpecificationMinMaxASSAY (DRIED BASIS)95%RETEST DATE

TestSpecificationMinMaxASSAY (by TITRATION)9.0-11.0 %9.0-11.0 %EXPIRATION DATE

TestSpecificationMinMaxASSAY [(CH[@3@])[@4@]NBr]98.00%98.00%TRIMETHYLAMINE (Me[@3@]N)0.50%TRIMETHYLAMINE (Me[@3@]N.HBr)0.50%POLAROGRAPHIC TESTTO PASS TESTTO PASS TEST