Test Specification Min Max VISCOSITY @ 33 +/- 3 �C 225 600 mPa.s pH of a 5 in 100 SUSPENSION 9 10 RATIO OF CONTENT ALUMINUM / MAGNESIUM 0.5 1.2...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% E-ISOMER 0.30% IRON (Fe) 0.01% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED IMPURITIES...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST...

Test Specification Min Max ASSAY 30 38.00% ALUMINUM CONTENT 15.5 18.50% CLARITY AND COLOR OF SOLUTION CLEAR AND CLEAR AND ACID NEUTRALIZING CAPACITY 12 mEq CHLORIDE (Cl) 0.50% ARSENIC (As)...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 100.50% pH OF A 1 IN 50 SOLUTION 3 4.5 COMPLETENESS OF SOLUTION TO PASS TEST LOSS ON DRYING 0.50% RESIDUE AFTER...

Test Specification Min Max SOLUBILITY TO PASS TEST TO PASS TEST MATTER-INSOLUBLE IN 5M AMMONIA RESIN OF P. PELTATUM 50 mg/0.50 RESIN OF P. HEXANDRUM 0.18-0.30 g/0.50 0.18-0.30 g/0.50 ETHANOL(96%)-INSOLUBLE...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% MELTING RANGE 143� - 148�C 143� - 148�C WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED CHROMATOGRAPHIC IMPURITIES...

Test Specification Min Max ASSAY (DRIED BASIS) 97 100.50% SPECIFIC ROTATION [a][@D@] -155� to -165� -155� to -165� LOSS ON DRYING 5.00% RELATED ALKALOIDS TO PASS TEST ELEMENTAL IMPURITIES TO...

Test Specification Min Max ASSAY (DRIED BASIS) 97.5 102.00% pH OF A 1 IN 100 SOLUTION 4.5 6 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.75% RESIDUE ON IGNITION...

Test Specification Min Max ASSAY (ANHYDROUS) 99 100.50% CLARITY OF SOLUTION TO PASS TEST RESIDUE ON IGNITION 15.5 16.50% WATER DETERMINATION 2.00% ELEMENTAL IMPURITIES AS REPORTED BIS(2-ETHYLHEXYL) MALEATE 0.40% IDENTIFICATION...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% MELTING RANGE 238� 242�C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORDINARY IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE Max. 3�C, betwe Max. 3�C, betwe SPECIFIC ROTATION [a][@D@] +79.5� to+82.5 +79.5� to+82.5 LOSS ON DRYING 2.00% READILY CARBONIZABLE...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99.0 - 100.5 % 99.0 - 100.5 % APPEARANCE OF SOLUTION TO PASS TEST pH OF A 1% SOLUTION 5.0 - 7.5 5.0...

Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 101.0 % 98.0 - 101.0 % COMPLETENESS AND COLOR OF SOLUTION TO PASS TEST TO PASS TEST MELTING RANGE 57 -...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% MELTING RANGE 65� 69�C WATER DETERMINATION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 870 - 1015 ug/mg 870 - 1015 ug/mg CRYSTALLINITY TO PASS TEST TO PASS TEST pH of a 1 in 4 Solution 4.5...

Test Specification Min Max ASSAY (DRIED BASIS) 95.0 - 102.0 % 95.0 - 102.0 % pH OF A 1 IN 10 SOLUTION 6.0 - 8.0 6.0 - 8.0 LOSS ON...

Test Specification Min Max ASSAY : BISMUTH (DRIED BASIS) 56 59.40% SALICYLATES (DRIED BASIS) 36.5 39.30% pH (10 g in 90 mL WATER) 2.7 5 LOSS ON DRYING 1.00% NITRATE...

Test Specification Min Max ASSAY (C[@25@]H[@34@]O[@8@]) 97.0 - 103.0 % 97.0 - 103.0 % SPECIFIC ROTATION [a][@D@] +124 to +134 +124 to +134 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% MELTING RANGE (WITHIN 3�C) 159� 165�C pH OF A 1 IN 100 SOLUTION 4.2 5.2 LOSS ON DRYING 0.40% CHROMATOGRAPHIC IMPURITIES...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +79 to +86 +79 to +86 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% RESIDUE ON IGNITION...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.50% MELTING RANGE (DRIED BASIS) 62.5� 66.0� CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% RESIDUE ON IGNITION...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +120� to +128� +120� to +128� WATER DETERMINATION 4.00% RESIDUE ON IGNITION 0.20% ORDINARY IMPURITIES TO PASS TEST...

Test Specification Min Max VISCOSITY OF A 2% AQUEOUS SOLUTION @ 20D [dC 75000 - 140000 m 75000 - 140000 m ASSAY (METHOXY GROUPS) 19.4 24.00% ASSAY (HYDROXYPROPOXY GROUPS) 4...

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% SULFATES (SO[@4@]) TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED SUGARS...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +97 to +103 +97 to +103 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00%...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% MELTING RANGE 136� 139�C pH OF A 1 IN 100 SOLUTION 4 5.5 WATER DETERMINATION 1.00% RESIDUE ON IGNITION 0.20% ORGANIC...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: PLATINUM (Pt) AS REPORTED AS REPORTED FREE p-AMINOPHENOL 0.01% ORGANIC IMPURITIES TO PASS TEST TO...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +118 to +126 +118 to +126 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ORDINARY IMPURITIES TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]25 -0.10 to +0.10� -0.10 to +0.10� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS...

Test Specification Min Max ASSAY {[-(CH[@3@])[@2@]SiO-]n} 90.5 99.00% CONTENT OF SILICON DIOXIDE 4 7.00% DEFOAMING ACTIVITY TO PASS TEST LOSS ON HEATING 18.00% ELEMENTAL IMPURITIES: NICKEL (Ni) AS REPORTED SILVER...

Test Specification Min Max ASSAY (Ca) 34 40.00% LOSS ON IGNITION 8.00% WATER-SOLUBLE SUBSTANCES 0.50% ACID-INSOLUBLE SUBSTANCES 0.20% CARBONATE (CO[@3@]) TO PASS TEST CHLORIDE (Cl) 0.14% FLUORIDE 75 ppm NITRATE...

Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% LOSS ON DRYING 2.00% ACID-INSOLUBLE SUBSTANCES 0.20% FLUORIDE 0.01% ARSENIC (As) 3 ppm BARIUM TO PASS TEST LEAD (Pb) 3 ppm...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION -15.3� to -17.0 -15.3� to -17.0 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% ELEMENTAL...

Test Specification Min Max ASSAY (IGNITED BASIS) 98 102.00% LOSS ON IGNITION 1.00% ALKALINITY TO PASS TEST TO PASS TEST CARBONATE AND COLOR OF SOLUTION TO PASS TEST TO PASS...

Test Specification Min Max ASSAY (C[@7@]H[@5@]O[@3@]Na; ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 0.50% SULFITE OR THIOSULFATE TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES:...