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                                            Benfotiamine
                                            Structural formula:Benfotiamine

                                            Product Name: Benserazide hydrochloride     
                                            Molecular Formula: C10H15N3O5·HCL
                                            Molecular Weight: 293.7
                                            CAS#: 14919-77-8

                                             

                                            ITEMS

                                             

                                            STANDARDS

                                             

                                            Result

                                                   

                                            Identification:

                                            IR

                                             

                                            Complies

                                            Opticalrotation

                                            -0.05to+o.o5

                                            +0.02

                                            PH

                                            4.0to 5.0

                                            4.2

                                            Impurity A

                                            ≤0.5%

                                             0.02%

                                            Individual other impurity

                                            ≤ 0.5%

                                            0.30%

                                            Total impurities :

                                            ≤1.0%

                                             0.32%

                                            Heavy metals:

                                            ≤10ppm

                                                   Complies

                                            Water

                                            ≤1.0%

                                             0.4%

                                            Sulfated ash

                                            ≤0.1%

                                             0.070%

                                            Assay on dry basis

                                             98.5%— 101.5%

                                            99.33%

                                            CONCLUSION:ACCORD WITH  EP7.0/BP2018


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