Test Specification Min Max ANGULAR ROTATION +91 to +96 +91 to +96 REFRACTIVE INDEX @ 20[dC 1.475 - 1.478 1.475 - 1.478 RESIDUE ON EVAPORATION 5.0 - 10.0 % 5.0...

Test Specification Min Max APPEARANCE

Test Specification Min Max APPEARANCE

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 3 4.50% pH 3.5 5 ORGANIC IMPURITIES TO PASS TEST TO PASS TEST RESIDUE ON IGNITION 0.30% HEAVY...

Test Specification Min Max ASSAY 98.5 101.50% CLARITY AND COLOR OF SOLUTION TO PASS TEST TO PASS TEST pH OF A 20% SOLUTION 3 5.5 ORGANIC IMPURITIES TO PASS TEST...

Test Specification Min Max ASSAY 400 USP oxytocin 400 USP oxytocin ACETIC ACID 6 10% MICROBIAL LIMITS 200 cfu/g ORDINARY IMPURITIES 5% ELEMENTAL IMPURITIES: PALLADIUM (Pd) AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY (C[@28@]H[@44@]O) 97 103.00% MELTING RANGE 115 119�C SPECIFIC ROTATION [a][@D@] +103� to +106� +103� to +106� REDUCING SUBSTANCES TO PASS TEST TO PASS TEST ELEMENTAL...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 5 8.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TEST 2: PANTOPRAZOLE RELATED COMPOUND C 0.10% PANTOPRAZOLE RELATED...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 95.0 - 102.0 % 95.0 - 102.0 % LEAD (Pb) 2 mg/kg RESIDUE ON IGNITION 0.30% WATER 8.50% IDENTIFICATION TO PASS TEST EXPIRATION...

Test Specification Min Max ASSAY (ALDEHYDES AS DECYL ALDEHYDE) 1.2 2.50% ANGULAR ROTATION +94� to +99� +94� to +99� REFRACTIVE INDEX @ 20[dC 1.472 1.474 SPECIFIC GRAVITY @ 25[dC 0.842...

Test Specification Min Max ASSAY (Na[@2@]CO[@3@]; DRY BASIS) 99.5 100.50% LOSS ON DRYING 12 15.00% LEAD (Pb) 4 mg/kg IDENTIFICATION TO PASS TEST EXPIRATION DATE

Test Specification Min Max ABSORPTION MAX 598 (380) nm 598 (380) nm ABSORPTION MAX 598 (380) nm 598 (380) nm VISUAL TRANSITION INTERVALS pH 3.8 (orange)t pH 3.8 (orange)t VISUAL...

Test Specification Min Max ASSAY (ANHYDROUS) 98 101.00% CLARITY AND COLOR OF SOLUTION TO PASS TEST TO PASS TEST WATER 12% RELATED SUBSTANCES TO PASS TEST TO PASS TEST IDENTIFICATION...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% OPTICAL ROTATION, [a] 20D -0.10 to +0.10 -0.10 to +0.10 RESIDUE ON IGNITION 0.10% LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO...

Test Specification Min Max ASSAY 99% COLOR (APHA) 25 WATER 0.20%

Test Specification Min Max APPEARANCE

Test Specification Min Max ASSAY 99% 99%

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 SPECIFIC GRAVITY @60 C 0.815 0.88 MELTING RANGE 38� 60�C CONSISTENCY TO PASS TEST STABILIZER (BUTYLHYDROXYTOLUENE) 20 ppm COLOR TO PASS TEST ACIDITY TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% MELTING RANGE 114� - 117�C 114� - 117�C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL...

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 (ANHYDROUS BASIS) 98 102.00% MELTING RANGE (WITHIN 4�C) 162� 171�C pH OF A 10% SOLUTION 6.4 6.8 WATER DETERMINATION 1.00% RESIDUE ON IGNITION 0.20% SELENIUM...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% pH OF A 1 IN 10 SOLUTION 2 3 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED...

Test Specification Min Max FDA LOT NUMBER TOTAL COLOR 85% ARSENIC (As) 3 ppm CHROMIUM (as Cr) 50 ppm N-ETHYL,N-(M-SULFOBENZYL)SULFANILIC ACID 0.30% LEAD (Pb) 10 ppm LEUCO BASE 5% SUM...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]20 -28.6 to -35.0 -28.6 to -35.0 WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.20% SULFAMATE 0.10% SULFATE 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 97% 97%

Test Specification Min Max CERTIFICATION LOT NUMBER: ASSAY 87% SUM OF VOLATILE MATER(@135C),[nCl &SO[@4@] 13.00% WATER-INSOLUBLE MATTER 0.20% AMINODIMETHYLBENZENESULFONIC ACID 0.20% HYDROXYNAPHTHALENESULFONIC ACID 0.20% SUBSIDIARY COLORS 2% LEAD (Pb) 20...

Test Specification Min Max EXPIRATION DATE

Test Specification Min Max ASSAY (C[@6@]H[@14@]N[@2@]O[@2@].HCl; DRIED BASIS) 98.5 101.50% OPTICAL ROTATION, @ 20D +20.3 to +21.5 +20.3 to +21.5 LEAD 5 mg/kg LOSS ON DRYING 1.00% RESIDUE ON IGNITION...

Test Specification Min Max ASSAY 99% 99%

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 (LiBO[@2@]) 98.0-102.0 % 98.0-102.0 % BULK DENSITY 0.25 g/ml 0.25 g/ml INSOLUBLE MATTER 0.01% LOSS ON FUSION @ 950[dC 2.00% SILICON (Si) 0.01% ALUMINUM 0.00%...

Test Specification Min Max APPEARANCE EXPIRATION DATE DATE OF MANUFACTURE

Test Specification Min Max ASSAY 99% RETEST DATE