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...

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...

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...

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...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% OPTICAL ROTATION +91 to +98 +91 to +98 LOSS ON DRYING 2.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED TRIAMCINOLONE ACETONIDE 1.00%...

Test Specification Min Max POTENCY (DRIED BASIS) 800 IU/mg pH OF A 2.5% AQUEOUS SOLUTION 5.0 - 7.2 5.0 - 7.2 COMPOSITION TO PASS TEST TO PASS TEST TYRAMINE 0.35%...

Test Specification Min Max VISCOSITY OF A 1% SOLUTION 250 cps 250 cps ARSENIC (As) 3 mg/kg TOTAL ASH 3.00% ACID-INSOLUBLE ASH 0.50% HEAVY METALS (as Pb) 0.00% KARAYA GUM...

Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5 % 99.0 - 100.5 % ACID-SOLUBLE SUBSTANCES 0.50% ALUMINUM OXIDE AND/OR SILICON DIOXIDE 2.00% ANTIMONY (Sb) 2 mg/kg ARSENIC (As)...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@] -26.7 to -29.1??/td> -26.7 to -29.1??/td> pH OF A 1 IN 20 SOLUTION 5 6.5 LOSS ON DRYING...

Test Specification Min Max ASSAY (C[@29@]H[@50@]O[@2@]) 96.0 - 102.0 % 96.0 - 102.0 % ACIDITY TO PASS TEST LEAD (Pb) 2 mg/kg IDENTIFICATION TO PASS TEST EXPIRATION DATE

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% TRAZODONE RELATED COMPOUND F 2.5 ??/g CYCLOPHOSPHAMIDE RELATED COMPOUND A 2.5 ??/g ORGANIC...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH OF A 2% SOLUTION 3.8 4.3 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (C[@19@]H[@22@]N[@2@][-HCl; ANHYDROUS BASIS) 98.0 - 101.0 % 98.0 - 101.0 % WATER 4.0 - 6.0 % 4.0 - 6.0 % CHROMATOGRAPHIC PURITY TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% CHROMATOGRAPHIC PURITY . . INDIVIDUAL IMPURITY 0.10% TOTAL IMPURITIES 1.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 199?? 203?? LOSS ON DRYING 0.50% CHROMATOGRAPHIC IMPURITIES (TOTAL) TO PASS TEST RESIDUE ON IGNITION 0.10% IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY (C[@9@]H[@14@]O[@6@]) 98.50% ACIDITY TO PASS TEST TO PASS TEST REFRACTIVE INDEX @ 25[dC 1.429 1.431 SPECIFIC GRAVITY @ 25[dC 1.154 1.158 LEAD (Pb) 1 mg/kg...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% ORGANIC IMPURITIES: TRIAMTERENE RELATED COMPOUND A 0.10% TRIAMTERENE RELATED COMPOUND B 0.15% TRIAMTERENE RELATED COMPOUND C 0.15%...

Test Specification Min Max MAGNESIUM (Mg) 17 19.50% ABSENCE OF ASBESTOS, PROCEDURE 2 NEGATIVE NEGATIVE MICROBIAL LIMITS: TOTAL AEROBIC MICROBIAL COUNT (TAMC) 100 cfu/g TOTAL YEAST AND MOLD COUNT (TYMC)...

Test Specification Min Max ACID-SOLUBLE SUBSTANCES (as SO[@4@]) 2.50% ARSENIC (As) 3 mg/kg FREE ALKALI (as NaOH) 1% LEAD (Pb) 5 mg/kg LOSS ON DRYING 0.50% LOSS ON IGNITION 6.00%...

Test Specification Min Max ASSAY (FATTY ACIDS) 63 71.00% ASSAY (POLYOLS; w/w) 32 38.00% HYDROXYL VALUE 275 305 SAPONIFICATION VALUE 140 150 ACID VALUE 8 WATER DETERMINATION 1.50% RESIDUE ON...

Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% MELTING RANGE 190?? 193?? ACIDITY TO PASS TEST CLARITY AND COLOR OF SOLUTION TO PASS TEST LOSS ON DRYING 0.50% RESIDUE...

Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% MELTING RANGE 197??- 200?? 197??- 200?? CLARITY AND COLOR OF SOLUTION TO PASS TEST ACIDITY TO PASS...

Test Specification Min Max ASSAY (C[@10@]H[@10@]N[@4@]O[@2@]S) 98 102.00% CLARITY AND COLOR OF SOLUTION TO PASS TEST ACIDITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES...