Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES . . TINIDAZOLE RELATED COMPOUND A 0.20%...

Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 100.5% 97.0 - 100.5% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 2.00% RESIDUE ON IGNITION 0.10% ELEMENTAL...

Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% LOSS ON DRYING 55 64.00% INSOLUBLE SUBSTANCES 0.40% CHLORIDE (Cl) 0.06% SULFATE 0.20% ARSENIC (As) 16 ppm ELEMENTAL IMPURITIES AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 98.0-102.0 % 98.0-102.0 % CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% RELATED SUBSTANCES: . . IMPURITY B 0.15% IMPURITY E 0.05% UNSPECIFIED IMPURITIES 0.10 % each TOTAL IMPURITIES 0.30% LOSS ON DRYING...

Test Specification Min Max POTENCY 90.0 - 110.0 % 90.0 - 110.0 % ASSAY (DRIED BASIS) 2500 U/mg SOLUBILITY TO PASS TEST MICROBIAL LIMITS TO PASS TEST LOSS ON DRYING...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +72 to +80 +72 to +80 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION...

Test Specification Min Max APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST ASSAY (DRIED BASIS) 90 110.00% CHROMATOGRAPHIC PURITY 92% NITROGEN 21 26.00% SULFATE (DRIED BASIS) 16 22% ULTRAVIOLET...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% RELATED SUBSTANCES TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% SULFATED ASH 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (Se) 52 55.50% RESIDUE ON IGNITION 0.20% SOLUBLE SELENIUM COMPOUNDS 5 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +118� to +130� +118� to +130� LOSS ON DRYING 1.50% CHROMATOGRAPHIC PURITY TO PASS TEST ELEMENTAL IMPURITIES AS...

Test Specification Min Max ASSAY (DRIED BASIS) 96.0 - 100.5 % 96.0 - 100.5 % LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.50% FREE IODINE AND IODIDE: IODINE TO PASS...

Test Specification Min Max SAPONIFICATION VALUE 40 50 HYDROXYL VALUE 96 108 WATER DETERMINATION 3.00% PEROXIDE VALUE 10 ACID VALUE 2 RESIDUE ON IGNITION 0.25% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS...

Test Specification Min Max ASSAY 96 98.00% SPECIFIC GRAVITY @ 25[dC 0.713 0.716 ACIDITY (as CH[@3@]COOH) 0.00% NONVOLATILE RESIDUE 0.00% ALDEHYDE TO PASS TEST PEROXIDE 0.3 ppm LOW BOILING HYDROCARBONS...

Test Specification Min Max ASSAY 97 102.00% SPECIFIC GRAVITY @ 20[dC 0.807 0.81 REFRACTIVE INDEX @ 20[dC 1.451 1.4525 ACID VALUE 0.2 IODINE VALUE 4 SAPONIFICATION VALUE 2 RESIDUE ON...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 2.50% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES TO PASS TEST IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION -16.7� to -22.7 -16.7� to -22.7 pH OF A 0.1% SOLUTION @ 20[dC 4.4 5.4 LOSS ON DRYING 4.00%...

Test Specification Min Max ASSAY (DIPHENHYDRAMINE; DRIED BASIS) 53 55.50% ASSAY (8-CHLOROTHEOPHYLLINE; DRIED BASIS) 44 47.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.30% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL...

Test Specification Min Max ASSAY (Al[@2@]O[@3@]; DRIED BASIS) 14.7 16.70% STEARIC AND PALMITIC ACID: STEARIC ACID 40.00% SUM OF STEARIC AND PALMITIC ACID 90.00% LOSS ON DRYING 3.00% ACIDITY AND...

Test Specification Min Max ASSAY (STEARIC ACID AND PALMITIC ACID) 90% ASSAY (STEARIC ACID) AS REPORTED AS REPORTED ACID VALUE 196 211 ACIDITY (AS STEARIC ACID) 0.28 1.20% LOSS ON...

Test Specification Min Max ASSAY (DRIED BASIS) 97 101.50% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES: LEAD (Pb) AS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 101.50% MELTING RANGE 162 165�C SPECIFIC ROTATION [a][@D@](C=0.04;water) -1.0 to +1.0� -1.0 to +1.0� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% CHLORIDE (Cl) 0.04% SELENIUM (Se) 30 ppm ELEMENTAL IMPURITIES: NICKEL (Ni) AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST ACIDITY (as ACETIC ACID) 0.30% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20%...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% (Z)-ISOMER 13.6 18.10% (E)-ISOMER 81.4 88.20% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED ORGANIC IMPURITIES TO...

Test Specification Min Max ASSAY (C[@16@]H[@24@]N[@2@].HCl; DRIED BASIS) 99 101.00% pH (in to 20 Solution) 5 6.6 LOSS ON DRYING 0.50% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST RESIDUE...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% IDENTIFICATION TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO...

Test Specification Min Max ASSAY (DRIED BASIS) 97 100.50% SPECIFIC ROTATION [a][@D@] -50.0� to -54.0 -50.0� to -54.0 LOSS ON DRYING 2.00% RESIDUE ON IGNITION NEGLIGIBLE NEGLIGIBLE ADRENALONE TO PASS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST PHOSPHORUS 100 ppm RESIDUE ON IGNITION 0.10% WATER DETERMINATION 12.00% IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY (KNaC[@4@]H[@4@]O[@6@]) 99 102.00% ALKALINITY TO PASS TEST WATER DETERMINATION 21 27.00% AMMONIA (NH[@3@]) TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% HYDRAZINE 10 ppm ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% MELTING RANGE 99� 103�C LOSS ON DRYING 0.50% RESIDUE AFTER IGNITION 0.10% RELATED COMPOUNDS AS REPORTED INDIVIDUAL 0.30% TOTAL 1.00% ELEMENTAL...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 102.00% WATER DETERMINATION 5.00% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% CLARITY OF SOLUTION TO PASS TEST TO PASS TEST pH (1 in 40 suspension) 3.5 4.5 LOSS ON DRYING 0.50% RESIDUE...

Test Specification Min Max AMMONIA (NH[@3@]) 2.50% TOTAL SULFUR (S) 10.00% LOSS ON DRYING 50.00% RESIDUE ON IGNITION 0.50% AMMONIUM SULFATE 8.00% ELEMENTAL IMPURITIES: ARSENIC (As) AS REPORTED AS REPORTED...