TestSpecificationMinMaxAPPEARANCEWHITE CRYSTALSWHITE CRYSTALSASSAY98%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...
TestSpecificationMinMaxAPPEARANCEWHITE CRYSTALLINWHITE CRYSTALLINMELTING POINT80� - 102�C80� - 102�C
TestSpecificationMinMaxFATTY ACID COMPOSITION (GC)C18:170%C18:215%C1615%
TestSpecificationMinMaxPURITY (Nonaqueous Titration; Dried Basis)99.0-101.0 %99.0-101.0 %
TestSpecificationMinMaxASSAY98%pKa @ 25 C6.58LOSS ON DRYING0.20%
TestSpecificationMinMaxPURITY (GC)96.00%REFRACTIVE INDEX @ 20�C1.4250 - 1.42801.4250 - 1.4280
TestSpecificationMinMaxSPECIFIC ROTATION, [a][@D@]20+37� to +42�+37� to +42�
TestSpecificationMinMaxSPECIFIC 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...
TestSpecificationMinMaxAPPEARANCE
TestSpecificationMinMaxASSAY97.0 - 102.0 %97.0 - 102.0 %SPECIFIC ROTATION, [a][@D@](C = 1)-18 to-22-18 to-22EXPIRATION 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...
TestSpecificationMinMaxASSAY (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...
TestSpecificationMinMaxASSAY (C[@6@]H[@12@]N[@4@])99.00%LOSS ON DRYING2.00%RESIDUE AFTER IGNITION0.10%HEAVY METALS (as Pb)0.00%