Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% COMPLETENESS OF SOLUTION TO PASS TEST SPECIFIC ROTATION [a][@D@] -187??to -197??/td> -187??to -197??/td> CHLORIDE (Cl) 9.2 9.58% WATER DETERMINATION AS REPORTED...
Test Specification Min Max ASSAY 98.0 - 102.0% 98.0 - 102.0% MELTING RANGE OF FREE BASE 228??- 235?? 228??- 235?? HEAVY METALS 0.00% WATER 7.50% IDENTIFICATION TO PASS TEST TO...
Test Specification Min Max ASSAY (DRIED BASIS) 98 100.50% SPECIFIC ROTATION [a][@D@] -170??to -181??/td> -170??to -181??/td> CHLORIDE CONTENT (DRIED BASIS) 9.54 9.94% NOROXYMORPHONE HCl AND OTHER[nIMPURITIES TO PASS TEST LOSS...
TestSpecificationMinMaxASSAYAPPROX. 98 %APPROX. 98 %RETEST DATE
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0% 98.0 - 102.0% MELTING RANGE 171 - 176 C (dec 171 - 176 C (dec LOSS ON DRYING 2.00% RESIDUE...
TestSpecificationMinMaxAPPEARANCE
TestSpecificationMinMaxASSAY99%99%
TestSpecificationMinMaxASSAY95%COPPER (Cu)0.01%IRON (Fe)0.01%
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION +83.0 to+89.5??/td> +83.0 to+89.5??/td> CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% ELEMENTAL IMPURITIES: NICKEL...
TestSpecificationMinMaxSENSITIVITY TO SULFANILAMIDETO PASS TESTTO PASS TESTSOLUBILITYTO PASS TESTTO PASS TESTWATER5%
TestSpecificationMinMaxASSAY99%pH OF A 10% SOLUTION03-May03-MayUV ABSORBANCE (@ 250 nm, 1M)0.1LOSS ON DRYING @ 110[dC1.00%RETEST DATE
TestSpecificationMinMaxASSAY94%SPECIFIC GRAVITY @ 25[dC1.010 - 1.0301.010 - 1.030REFRACTIVE INDEX @ 20[dC1.529 - 1.5311.529 - 1.531RETEST DATE
Test Specification Min Max ASSAY (C[@4@]H[@6@]O[@5@]) 99.0 - 100.5 % 99.0 - 100.5 % OPTICAL ROTATION -0.10 to+0.10 -0.10 to+0.10 FUMARIC ACID 1.00% LEAD (Pb) 2 mg/kg MALEIC ACID 0.05%...
TestSpecificationMinMaxABSORPTION MAX614 (425) nm614 (425) nmVISUAL TRANSITION INTERVALSpH 0.0 (yellow)pH 0.0 (yellow)
TestSpecificationMinMaxABSORPTION MAXApprox. 615 (425Approx. 615 (425
Test Specification Min Max ASSAY (MgSO[@4@]; ANHYDROUS BASIS) 99 100.50% pH OF A 5% SOLUTION @ 25[dC 5 9.2 LOSS ON IGNITION 48 52.00% APPEARANCE OF SOLUTION TO PASS TEST...
Test Specification Min Max ASSAY 98 103.00% MAGNESIUM CONTENT 6.3 6.70% WATER DETERMINATION 17.5 21.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION...
Test Specification Min Max ASSAY 96 100.50% BULK DENSITY 0.25 0.5 g/cc LOSS ON IGNITION 10.00% FREE ALKALI & SOLUBLE SALTS TO PASS TEST TO PASS TEST ACID-INSOLUBLE SUBSTANCES 0.10%...
TestSpecificationMinMaxMAGNESIUM CONTENT (DRY BASIS)11.00%LOSS ON DRYING12.00%
TestSpecificationMinMaxASSAY (MgCl[@2@][-6H[@2@]O)99.0 - 105.0%99.0 - 105.0%AMMONIUM (NH[@4@])0.01%LEAD (Pb)4 mg/kgSULFATE0.03%IDENTIFICATIONTO PASS TESTEXPIRATION DATE
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97.0 - 102.0 % 97.0 - 102.0 % WATER 5.00% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL...
Test Specification Min Max ASSAY 98 102.00% SOLUBILITY IN 70% ALCOHOL TO PASS TEST TO PASS TEST SPECIFIC GRAVITY @ 25[d/25[dC 1.18 1.185 ANGULAR ROTATION OPTICALLY INACTI OPTICALLY INACTI DIMETHYL...
TestSpecificationMinMaxCLARITY OF SOLUTIONTO PASS TESTTO PASS TESTVISUAL TRANSITION INTERVALSpH 3.2 (pink) topH 3.2 (pink) to
Test Specification Min Max ASSAY 99.50% ACIDITY TO PASS TEST TO PASS TEST ALKALINITY (AS AMMONIA) 3 ppm WATER DETERMINATION 0.10% NONVOLATILE RESIDUE 0.001 %(w/w) READILY CARBONIZABLE SUBSTANCES TO PASS...
TestSpecificationMinMaxABSORPTION MAX668 (609) nm668 (609) nm
TestSpecificationMinMaxABSORPTION MAXAPPROX. 661 nmAPPROX. 661 nm