Orphenadrine citrate

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COMPLY WITH USP30 STANDARD NAME ORFENADRINA CITRATOEXPIRY DATE2 yearsCAS NO.TestsResultsSpecificationCHARACTERSAppearanceCompliesWhite or almost white,crystalline powder.APPEARANCE OF SOLUTION(Current USP)10ml HCLAlcohol=127 Complies CompliesAbs.23 (Current USP)1g/10ml HCL /Alcohol=127-436nm 0.023 ≤0.050IDENTIFICATION(USP <815>)I.R.Spectrum Complies CompliesIDENTIFICATION(Current USP)UVAbsorbance difference 1.1% ≤3.0%PE23.7E(Current USP)Loss on drying 0.1% ≤0.5%TEST (USP<281>)Residue on ignition/sulphated asn 0.05% ≤0.1%RELATED SUBSTANCES (Current USP) Total impurities(HPLC) 0.3% ≤0.5%Assay (Current USP)Assay HPLC 99.5% 98.0-101.5%MELTING  POINTMelting range 136~138°C 134-138°CRELATED SUBSTANCES (USP)Ethyldimethyl[2-(2-methylbenzhydryloxy)ethyl]ammonium chloride ND ≤0.5%2-MethylbenzhydrolND≤0.5%N,N-Dimethyl-2-(o-tolyl-o-xylyloxy)ethylamineND≤0.5%others0.3%≤0.5%Total impurities0.3%≤0.5%ORGANIC VOLATILE  IMPURITIES(USP) Based on our knowledge of the manufacturing process and controlled handling and storage of this raw material,there is no potential for the organic volatile impurities listed relative to current USP <467>to be present(I.E..the listed impurities are not used in the manufacturing process,nor could they be introduced during the storage or handling of the raw material).RESIDUAL SOLVENTS (ICH-Q3C)Only class 3 solvents(CPMP/ICH/283/95)are likely to be present.Loss on drying is less than 0.5%GUARANTEE PERIODUses before this date 11/06/2012Lot ReleasedComplies with all specifications of the USP30Testing instruction