Test Specification Min Max ASSAY (DRIED BASIS) 97 101.00% LOSS ON DRYING @ 60�C 0.50% RESIDUE AFTER IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO...

Test Specification Min Max ASSAY (FREE ACID FORM; ANHYDROUS BASIS) 90 96.00% WATER DETERMINATION 14.5 17.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED DANTROLENE RELATED COMPOUND A 0.15% ORGANIC IMPURITIES TO...

Test Specification Min Max ASSAY (C[@23@]H[@36@]N[@2@]O[@2@]; ANHYDROUS BASIS) 98.5 101.00% SPECIFIC ROTATION -56.0 to -60.0� -56.0 to -60.0� CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST WATER DETERMINATION 0.30% RESIDUE...

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 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 97.5 101.50% pH OF A 1% SOLUTION 8 9 MONOETHANOLAMINE 223 230 mg/g RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED RELATED COMPOUNDS...

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 (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) 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) 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 ASSAY (C[@13@]H[@6@]Cl[@6@]O[@2@]) 98.0 - 100.5 % 98.0 - 100.5 % MELTING POINT 161 - 167 C 161 - 167 C LOSS ON DRYING 1.00% RESIDUE ON...

Test Specification Min Max ASSAY (ANHYDROUS, SOLVENT FREE BASIS) 98 101.00% SPECIFIC ROTATION +32� to +36� +32� to +36� ACETONE 1.00% WATER DETERMINATION 0.20% ORGANIC IMPURITIES TO PASS TEST TO...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 160� 164�C pH OF A 1 IN 100 SOLUTION 5.6 7.5 RESIDUE ON IGNITION 0.15% CHLORIDE 0.04% SULFATE 0.01%...

Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% MELTING RANGE 200� - 204�C 200� - 204�C ACIDITY TO PASS TEST TO PASS TEST LOSS ON...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED PERCHLORIC ACID TITRATION TO PASS TEST TO...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% pH OF A 1 IN 100 SOLUTION 5.7 6.7 LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION...

Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION +21� to +27� +21� to +27� CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 2.00% ELEMENTAL IMPURITIES AS REPORTED...

Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 100.5% 97.0 - 100.5% MELTING RANGE (WITHIN 4�C) 169� - 175�C 169� - 175�C ACIDITY OR ALKALINITY TO PASS TEST LOSS...

Test Specification Min Max ASSAY (Sum of H[@2@]B[@1a@] and H[@2@]B[@1b@]; Dried, Alcohol & 95 102.00% & Formamide free Basis) RATIO (H[@2@]B[@1a@]/H[@2@]B[@1a@] + H[@2@]B[@1b@] 90% SPECIFIC ROTATION -17� to -20� -17�...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% ORGANIC IMPURITIES TO PASS TEST LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST CERTIFIED HALAL RETEST DATE...

Test Specification Min Max ASSAY (DRIED BASIS) 61.7- 65.5 % 61.7- 65.5 % CHOLINE 652 - 693 mg/g 652 - 693 mg/g MELTING RANGE 185 - 189 C 185 -...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 101.00% CHROMATOGRAPHIC PURITY TO PASS TEST WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 100.5 % 98.0 - 100.5 % SPECIFIC ROTATION +6.0�to +6.7� +6.0�to +6.7� AMINOBUTANOL 1.00% HEAVY METALS 20 ppm TOTAL STEREOISOMERS 4.00%...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% 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) 98.0 -101.0 % 98.0 -101.0 % pH OF A 1 IN 20 SOLUTION 1.7 - 2.6 1.7 - 2.6 LOSS ON DRYING 1.50%...

Test Specification Min Max ASSAY (ANHYDROUS, SOLVENT-FREE BASIS) 97 102.00% SPECIFIC ROTATION, [a][@D@]25 -49.0� to -55.0 -49.0� to -55.0 WATER DETERMINATION 4.00% RESIDUE ON IGNITION 0.20% HEAVY METALS 0.00% BACTERIAL...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 950 1030 ug/mg IDENTIFICATION TO PASS TEST TO PASS TEST OPTICAL ROTATION -75� to -88� -75� to -88� CRYSTALLINITY TO PASS TEST TO...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 100.50% pH OF A 5% SOLUTION @ 25[dC 8 9.5 SELENIUM (Se) 30 ppm ELEMENTAL IMPURITIES AS REPORTED AS REPORTED WATER DETERMINATION...

Test Specification Min Max POTENCY (C[@22@]H[@24@][N[@2@]O[@8@]) 800 920 �g/m CRYSTALLINITY TO PASS TEST TO PASS TEST pH OF A 10 mg/ml SOLUTION 2 3 WATER DETERMINATION 1.4 2.80% ETHANOL 4.3...