Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST ACIDITY TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% HEAVY METALS 10 ppm ORGANIC IMPURITIES TO PASS TEST TO PASS TEST LAMOTRIGINE...

Test Specification Min Max ANHYDROUS ALUMINUM CHLOROHYDRATE AS REPORTED AS REPORTED CONTENT OF ALUMINUM AS REPORTED AS REPORTED CONTENT OF CHLORIDE AS REPORTED AS REPORTED ALUMINUM/CHLORIDE ATOMIC RATIO 1.91:1 2.10:1...

Test Specification Min Max ALKALINITY TO PASS TEST TO PASS TEST CHLORIDE 0.36% SULFATE 1.00% LOSS ON DRYING 10.00% RESIDUE ON IGNITION 10 20.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...

Test Specification Min Max ASSAY 98 102.00% HEAVY METALS 10 ppm ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.10% WATER DETERMINATION 0.30% IDENTIFICATION TO PASS TEST RESIDUAL SOLVENTS TO...

Test Specification Min Max ASSAY (DRIED BASIS) 99 102.00% MELTING RANGE 64.5 68.5�C SPECIFIC ROTATION [a][@D@] -0.05 to +0.05� -0.05 to +0.05� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...

Test Specification Min Max APPEARANCE

Test Specification Min Max PURITY (GC) 97.00% MELTING POINT 84.0 - 87.0�C 84.0 - 87.0�C

Test Specification Min Max ASSAY (AS NITROGEN; DRIED BASIS) 26 28.00% COLOR AND CLARITY OF SOLUTION TO PASS TEST TO PASS TEST pH OF A 1% SOLUTION 6 7.5 LOSS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH OF A 1 % SOLUTION @ 25[dC 5.2 6.5 WATER DETERMINATION 3.5 5.50% RESIDUE ON IGNITION 0.10% N,N-DIMETHYLANILINE 0.00% PHENOLIC...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]20 +6.5� to+10.5� +6.5� to+10.5� pH OF A 1 IN 10 SOLUTION 6 7 LOSS ON DRYING 0.50% RESIDUE...

Test Specification Min Max ASSAY [METHOXYL GROUPS (-OCH[@3@]); DRIED BASIS] 27.5 31.50% VISCOSITY OF A 2g IN 100 ml SOLN 300 560 cP LEAD (Pb) 3 mg/kg LOSS ON DRYING...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99.00% MELTING RANGE 160 - 164 C 160 - 164 C RESIDUE ON IGNITION 0.20% WATER 0.50% IDENTIFICATION TO PASS TEST TO PASS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% CHLORIDE 0.01% SULFATE 0.04% SELENIUM 30 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED SILVER...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % OPTICAL ROTATION +21.0 to+25.0 +21.0 to+25.0 LEAD (Pb) 5 mg/kg LOSS ON DRYING 0.50% RESIDUE...

Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% LOSS ON DRYING 0.50% ORGANIC IMPURITIES 1.50% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION SPECTRUM MATCHES SPECTRUM...

Test Specification Min Max ASSAY 97.5 102.50% CHLORIDE (Cl) 0.00% RESIDUE ON IGNITION 0.10% SULFATE 0.10% ORGANIC IMPURITIES: LIDOCAINE RELATED COMPOUND H 0.10% 2,6- DIMETHYLANILINE 0.01% ANY UNSPECIFIED IMPURITY 0.10%...

Test Specification Min Max ASSAY (DRIED BASIS) 97.5 100.50% MELTING RANGE 119� 125�C pH OF A 10% SOLUTION 7 8.5 LOSS ON DRYING 10.5 12.00% CHLORIDE 0.07% SULFATE 0.05% ARSENIC...

Test Specification Min Max HYDROXYL VALUE 154 162 SAPONIFICATION VALUE 176 182 ALKALINE IMPURITY TO PASS TEST TO PASS TEST TRIGLYCERIDE COMPOSITION TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...

Test Specification Min Max ASSAY (SnCl[@2@][-2H[@2@]O) 98.0 - 103.0 % 98.0 - 103.0 % SOLUBILITY IN HCl TO PASS TEST SULFATES (SO[@4@]) TO PASS TEST CALCIUM (Ca) 0.01% POTASSIUM (K)...

Test Specification Min Max ASSAY (NH[@4@]HCO[@3@]) 99.0 - 100.5% 99.0 - 100.5% CHLORIDE (Cl) 0.00% LEAD (Pb) 3 mg/kg NONVOLATILE RESIDUE 0.55% SULFUR COMPOUNDS 0.01% IDENTIFICATION TO PASS TEST RETEST...

Test Specification Min Max ASSAY [Al[@2@](SO[@4@])[@3@]] 99.5-114.0 % 99.5-114.0 % ALKALIES AND ALKALINE EARTHS TO PASS TEST(lim TO PASS TEST(lim AMMONIUM SALTS TO PASS TEST TO PASS TEST FLUORIDE 0.00%...

Test Specification Min Max ACIDITY TO PASS TEST TO PASS TEST COLOR (APHA) 10 RESIDUE AFTER EVAPORATION 0.00% BOILING RANGE 35 - 60�C 35 - 60�C

Test Specification Min Max ASSAY (DRIED BASIS) 98 103.00% LOSS ON DRYING 10 15.00% ARSENIC (As) 3 mg/kg FLUORIDE 0.01% INSOLUBLE SUBSTANCES 0.20% LEAD (Pb) 4 mg/kg IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 100.50% LOSS ON DRYING 33 36.50% SODIUM (Na) 0.02% POTASSIUM (K) 0.01% CALCIUM (Ca) 0.01% IRON (Fe) 0.00% NICKEL (Ni) 0.01% ELEMENTAL...

Test Specification Min Max FDA LOT NUMBER DYE CONTENT HEAVY METAL: MERCURY (Hg) LEAD (Pb) ARSENIC (As) IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE

Test Specification Min Max APPEARANCE

Test Specification Min Max ASSAY (Na[@2@]C[@2@]O[@4@]) 99.95-100.05 % 99.95-100.05 % NEUTRALITY TO PASS TEST INSOLUBLE MATTER 0.01% LOSS ON DRYING @ 105 C 0.01% CHLORIDE (Cl) 0.00% SULFATES (SO[@4@]) 0.00%...

Test Specification Min Max ASSAY (C[@31@]H[@52@]O[@3@]) 96 102.00% ACIDITY TO PASS TEST LEAD (Pb) 2 mg/kg IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE

Test Specification Min Max ASSAY (C[@5@]H[@11@]NO[@2@]; DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % OPTICAL ROTATION, [a] 20D +26.7 to +29.0 +26.7 to +29.0 LEAD 5 mg/kg LOSS...

Test Specification Min Max ASSAY (Na[@2@]C[@4@]H[@4@]O[@6@][-2H[@2@]O) 99.0-101.0 % 99.0-101.0 % LOSS ON DRYING @ 150[dC 15.61-15.71 % 15.61-15.71 % pH OF A 5% SOLUTION @ 25[dC 7.0 - 9.0 7.0...