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Specifications Formula: HOCH2(CHOH)4CH2OHFormula Weight: 182.17CAS Number: 69-65-8GMP Manufactured ProductMeets U.S.P. RequirementsAssay (as HOCH2(CHOH)4CH2OH) (calculated on anhydrous basis)96.0 - 101.5 %AcidityPasses TestArsenic (As)max. 1 ppmChloride (Cl)max. 0.007 %IdentificationPasses TestLoss on Drying at 105°Cmax. 0.3 %Melting Range164 - 169°CReducing SugarsPasses TestSpecific Rotation [a]25D+ 137 - 145Sulfate (SO4)max. 0.01 %Meets BP/Ph.Eur. Chemical SpecificationsAssay (as HOCH2(CHOH)4CH2OH) (calculated on anhydrous basis)98.0 - 102.0 %Identification APasses TestIdentification BPasses TestIdentification CPasses TestIdentification DPasses TestAppearance of SolutionPasses TestConductivity, µS cm-1max. 20Reducing Sugarsmax. 0.2 %Related SubstancesPasses TestLead (Pb)max. 0.5 ppmNickel (Ni)max. 1 ppmWater (H2O)max. 0.5 %Endotoxin Concentration, <2.5 IU/gPasses TestTotal Viable Aerobic Count (cfu):Bacterial Count (per g)max. 100Fungi Count (per g)max. 100Eschericha coli and SalmonellaPasses TestMeets JP Chemical SpecificationsAssay (as HOCH2(CHOH)4CH2OH) (calculated on anhydrous basis)98.0 - 101.0 %Identification APasses TestIdentification BPasses TestSpecific Rotation [a]25D+ 137 - 145Melting Point166 - 169°CClarity and ColorPasses TestAcidityPasses TestChloride (Cl)max. 0.007 %Sulfate (SO4)max. 0.010 %Heavy Metals (as Pb)max. 5 ppmNickel (Ni)Passes TestArsenic (As)max. 1.3 ppmSugarsPasses TestLoss on Drying at 105°Cmax. 0.30 %Residue on Ignitionmax. 0.10 %
