Test Specification Min Max ASSAY 99.0 - 101.0 % 99.0 - 101.0 % INSOLUBLE MATTER 0.01% RESIDUE AFTER IGNITION 0.01% OTHER HALOGENS (as Cl) 0.01% SULFATE (SO[@4@]) 0.01% HEAVY METALS...
Test Specification Min Max ASSAY (KH[@2@]PO[@4@]) 99.00% pH OF A 5% SOLUTION @ 25[dC 4.1 - 4.5 4.1 - 4.5 INSOLUBLE MATTER 0.01% LOSS ON DRYING 0.20% CHLORIDE (Cl) 0.00%...
Test Specification Min Max COMPLETENESS AND COLOR OF SOLUTION TO PASS TEST TO PASS TEST pH OF A 5% SOLUTION @ 25[dC 4.5 - 7.5 4.5 - 7.5 RESIDUE ON...
TestSpecificationMinMaxASSAYAPPROX.99.8%APPROX.99.8%WATER (100 ml size)0.01%WATER (1L size)0.00%RESIDUE AFTER EVAPORATION0.00%RETEST DATE
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 101.5 % 98.0 - 101.5 % SPECIFIC ROTATION, [a][@D@]20 +5.0 to +8.0 +5.0 to +8.0 LOSS ON DRYING 8 - 12...
Test Specification Min Max ASSAY (by GC) 99.90% STABILIZER 0.5 - 1.0 % 0.5 - 1.0 % COLOR (APHA) 10 LIQUID CHROMATOGRAPHY TO PASS TEST TO PASS TEST ULTRAVIOLET ABSORBANCE...
Test Specification Min Max ASSAY [CH[@3@](CH[@2@])[@3@]OH] 99.40% COLOR (APHA) 10 RESIDUE AFTER EVAPORATION 0.01% TITRABLE ACID 0.0008 meq CARBONYL COMPOUNDS (AS BUTYRALDEHYDE) 0.01% BUTYL ETHER 0.20% WATER 0.10% IDENTIFICATION TO...
Test Specification Min Max ASSAY (by GC) 99.90% ULTRAVIOLET ABSORBANCE (1 cm cell vs. water) @ 190 nm 1 @ 200 nm 0.05 @ 210 nm 0.04 @ 220 nm...
TestSpecificationMinMaxpH7.3 - 7.57.3 - 7.5DNaseNONE DETECTEDNONE DETECTEDSTERILITYTO PASS TESTTO PASS TESTRETEST DATE
Test Specification Min Max ASSAY (Na[@2@]HPO[@4@]) 99.00% 99.00% pH OF A 5% SOLUTION @ 25[dC 8.7 9.3 INSOLUBLE MATTER 0.01% LOSS ON DRYING @ 105 C 0.20% CHLORIDE (Cl) 0.00%...
TestSpecificationMinMaxASSAYAPPROX.99 %APPROX.99 %WATER0.01%RESIDUE AFTER EVAPORATION0.00%RETEST DATE
TestSpecificationMinMaxPURITY (by TLC)ONE SPOTONE SPOTABSORBANCE OF A 5% SOLUTION @ 300 nm0.1 A.U
TestSpecificationMinMaxASSAY (DRIED BASIS)98.00%MOISTURE8.00%
TestSpecificationMinMaxASSAYAPPROX. 99 %APPROX. 99 %APPEARANCEFINE,WHITE,FINE,WHITE,SOLUBILITY (1% IN WATER)CLEAR, HAZE FREECLEAR, HAZE FREE
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.5 % 98.5 - 101.5 % SPECIFIC ROTATION [a][@D@] +21.3 to+23.5 +21.3 to+23.5 LOSS ON DRYING @ 105 C 0.30% RESIDUE...
Test Specification Min Max APPEARANCE TO PASS TEST TO PASS TEST GEL TEMPERATURE (1.5%) 36 - 39 C 36 - 39 C EEO 0.1 SULFATE 0.30% ASH 0.50% MOISTURE 10.00%...
TestSpecificationMinMaxASSAY98%
Test Specification Min Max ASSAY (KI) 99.00% pH OF A 5% SOLUTION @ 25[dC 6.0 - 9.2 6.0 - 9.2 INSOLUBLE MATTER 0.01% LOSS ON DRYING @ 150[dC 0.20% CHLORIDE...
Test Specification Min Max ASSAY (NaNO[@3@]) 99.00% pH OF A 5% SOLUTION @ 25[dC 5.5 8.3 INSOLUBLE MATTER 0.01% CHLORIDE (Cl) 0.00% IODATE (IO[@3@]) 5 ppm NITRITE (NO[@2@]) 0.00% PHOSPHATE...
Test Specification Min Max pH 6.0 +/- 1.0 @ 20 6.0 +/- 1.0 @ 20 STERILITY To pass test To pass test CONDUCTIVITY Meets USP requir Meets USP requir TOTAL...
Test Specification Min Max ASSAY (by GC) 99.70% SOLUBILITY IN WATER TO PASS TEST TO PASS TEST ULTRAVIOLET ABSORBANCE (1 cm cell vs. water) TO PASS TEST TO PASS TEST...
TestSpecificationMinMaxASSAY99%2,2-THIODIETHANOL0.50%DNase, RNase and ProteaseNONE DETECTEDNONE DETECTED
TestSpecificationMinMaxAPPEARANCEWHITE CRYSTALSWHITE CRYSTALSASSAY97%97%