Test Specification Min Max ASSAY (by TITRATION) 98% 98%

Test Specification Min Max ASSAY 99.50% LOSS ON DRYING 0.50%

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

Test Specification Min Max APPEARANCE WHITE CRYSTALS WHITE CRYSTALS ASSAY 98% 98%

Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 3.50% RESIDUE ON IGNITION 0.15% p-CHLOROANILINE 500 ppm ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION TO...

Test Specification Min Max APPEARANCE WHITE CRYSTALLIN WHITE CRYSTALLIN MELTING POINT 80� - 102�C 80� - 102�C

Test Specification Min Max ASSAY APPROX. 97 % APPROX. 97 %

Test Specification Min Max APPEARANCE

Test Specification Min Max FATTY ACID COMPOSITION (GC) C18:1 70% C18:2 15% C16 15%

Test Specification Min Max PURITY (Nonaqueous Titration; Dried Basis) 99.0 - 101.0 % 99.0 - 101.0 %

Test Specification Min Max ASSAY 98% pKa @ 25 C 6.58 LOSS ON DRYING 0.20%

Test Specification Min Max PURITY (GC) 96.00% REFRACTIVE INDEX @ 20�C 1.4250 - 1.4280 1.4250 - 1.4280

Test Specification Min Max ASSAY 98% 98%

Test Specification Min Max APPEARANCE

Test Specification Min Max SPECIFIC ROTATION, [a][@D@]20 +37� to +42� +37� to +42�

Test Specification Min Max SPECIFIC ROTATION -72� to -68� -72� to -68�

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 (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 APPEARANCE

Test Specification Min Max MOISTURE (KF) 10.00%

Test Specification Min Max APPEARANCE

Test Specification Min Max ASSAY 97.0 - 102.0 % 97.0 - 102.0 % SPECIFIC ROTATION, [a][@D@](C = 1) -18 to -22 -18 to -22 EXPIRATION DATE

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 (C[@2@]H[@6@]OS) 98% 98% RETEST DATE

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) 98.50% SPECIFIC ROTATION [a][@D@] +14.9� to +17.3 +14.9� to +17.3 LOSS ON DRYING @ 105 C 0.20% RESIDUE ON IGNITION 0.40% EXPIRATION DATE...

Test Specification Min Max ASSAY (C[@6@]H[@12@]N[@4@]) 99.00% LOSS ON DRYING 2.00% RESIDUE AFTER IGNITION 0.10% HEAVY METALS (as Pb) 0.00%