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...

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...

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 (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 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 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 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 (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 (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 (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 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...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 100.50% MELTING TEMPERATURE 78?? 78?? WATER DETERMINATION 1.00% ACIDITY TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO...

Test Specification Min Max ASSAY 98 102.00% pH 7 9 LOSS ON DRYING 0.25% AMMONIUM, IRON AND SELENIUM TO PASS TEST SODIUM NITRATE 0.40% CALCIUM AND POTASSIUM TO PASS TEST...

Test Specification Min Max ASSAY (SO[@2@]) 65 67.40% ASSAY (Na[@2@]S[@2@]O[@5@]) 95 100.50% pH (5% SOLUTION) 3.5 5 CHLORIDE (Cl) 0.05% IRON (Fe) 20 ppm THIOSULFATE (S[@2@]O[@3@]) 0.05% ELEMENTAL IMPURITIES AS...

Test Specification Min Max ASSAY (C[@3@]H[@5@]NaO[@3@]) 58.8 61.20% pH OF SOLUTION @ 25[dC 5 9 CHLORIDE (Cl) 0.05% CITRATE, OXALATE, PHOSPHATE OR TARTRATE TO PASS TEST SULFATES (SO[@4@]) TO PASS...

Test Specification Min Max ASSAY (Na[@2@]CO[@3@]) 99.5 100.50% WATER DETERMINATION 12 15.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% LOSS ON DRYING 43 50.00% INSOLUBLE MATTER 0.40% CHLORIDE (Cl) 0.06% SULFATE (SO[@4@]) 0.20% ARSENIC (As) 16 ppm ELEMENTAL IMPURITIES AS...

Test Specification Min Max ASSAY (NaH[@2@]PO[@4@]; ANHYDROUS BASIS) 98 100.50% pH OF A 5% SOLUTION (ACIDITY) 4.2 4.5 LOSS ON DRYING 11.5 14.50% WATER DETERMINATION 10 15.00% INSOLUBLE SUBSTANCES 0.20%...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO...