Test Specification Min Max ASSAY (C[@7@]H[@4@]NNaO[@3@]S; ANHYDROUS BASIS) 98 101.00% ALKALINITY TO PASS TEST BENZOATE AND SALICYLATE TO PASS TEST LEAD 2 mg/kg READILY CARBONIZABLE SUBSTANCES TO PASS TEST SELENIUM...

Test Specification Min Max THEOPHYLLINE (ANHYDROUS BASIS) 84 87.40% ETHYLENEDIAMINE (ANHYDROUS BASIS) 13.5 15.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST TO PASS...

Test Specification Min Max ASSAY APPROX. 99 % APPROX. 99 %

Test Specification Min Max ASSAY 98.5 102.00% SPECIFIC ROTATION [a][@D@] +18.5 to +22.5� +18.5 to +22.5� CHLORIDE (Cl) 0.07% SULFATE (SO[@4@]) 0.12% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED SUCROSE AND...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH 4.3 5.3 HEAVY METALS 20 ppm LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO...

Test Specification Min Max ASSAY (C[@6@]H[@10@]CaO[@6@]) 98.0 - 101.0 % 98.0 - 101.0 % LOSS ON DRYING 5.0 - 8.0 % 5.0 - 8.0 % ACIDITY (as LACTIC ACID) 0.45%...

Test Specification Min Max APPEARANCE

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 98.0 - 101.5 % 98.0 - 101.5 % pH 5.5 - 7.0 5.5 - 7.0 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% RESIDUE...

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

Test Specification Min Max pH (1% IN WATER) 6.7 - 7.3 6.7 - 7.3

Test Specification Min Max APPEARANCE White to off whi White to off whi ASSAY (ANHYDROUS, SOLVENT-FREE BASIS) 98 102.00% COMPLETENESS OF SOLUTION (in 0.1N HCl) TO PASS TEST TO PASS...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 101.50% pH OF 0.1% SOLUTION 5.5 6.5 OPTICAL ROTATION -0.10� to +0.10 -0.10� to +0.10 WATER 4 5.00% RELATED SUBSTANCES TO PASS...

Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% MELTING RANGE WITHIN 3.0 C WITHIN 3.0 C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% VOLATILE RELATED COMPOUNDS TO PASS...

Test Specification Min Max ASSAY (KETONES AS CARVONE ; BY VOLUME) 50.00% 50.00% ANGULAR ROTATION +70 to +80 +70 to +80 REFRACTIVE INDEX @ 20[dC 1.484- 1.488 1.484- 1.488 SOLUBILITY...

Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 199� 203�C LOSS ON DRYING 0.50% CHROMATOGRAPHIC PURITY TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: NICKEL (Ni)...

Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0 % 98.0 - 102.0 % LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% HEAVY METALS 0.00% SELENIUM 0.00% IDENTIFICATION TO...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 - 101.5 % 98.5 - 101.5 % pH OF A 1 IN 100 SOLUTION 4.5 6 WATER DETERMINATION 4 6.00% CHROMATOGRAPHIC PURITY...

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION +0.2� to -0.2� +0.2� to -0.2� pH OF A 1% SOLUTION 4 5 LOSS ON DRYING 0.50% RESIDUE ON...

Test Specification Min Max INSOLUBLE MATTER 0.01% CHLORIDE (Cl) 0.02% SULFATES (SO[@4@]) 0.03% AMMONIUM (NH[@4@]) 0.01% CALCIUM (Ca) 0.02% HEAVY METALS (as Pb) 0.01% IRON (Fe) 0.01%

Test Specification Min Max ASSAY (DRIED BASIS) 97 101.00% ACIDITY To pass test LOSS ON DRYING 0.50% RELATED SUBSTANCES To pass test SULFATED ASH 0.10% APPEARANCE RESIDUAL SOLVENTS To pass...

Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST TO PASS TEST WATER 0.50% SULFATED ASH...

Test Specification Min Max ASSAY 98 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST pH OF A 5% SOLUTION 10.5 12 RELATED SUBSTANCES TO PASS TEST TO PASS...

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...