Dopamine Hydrochloride
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C8H11NO2·HCl 189.64

1,2-Benzenediol,4-(2-aminoethyl)-,hydrochloride.
4-(2-Aminoethyl)pyrocatechol hydrochloride

[62-31-7].
»Dopamine Hydrochloride contains not less than 98.0percent and not more than 102.0percent of C8H11NO2·HCl,calculated on the dried basis.
Packaging and storage— Preserve in tight containers.Store at room temperature.
Clarity and color of solution— Asolution of 400mg in 10mLof sodium bisulfite solution (1in 1000)is clear and colorless or practically colorless.
Identification—
A:Infrared Absorption á197Kñ.
B:Ultraviolet Absorption á197Uñ
Solution: 40µg per mL.
Medium: sodium bisulfite in water (1in 1000).
C: It responds to the tests for Chloride á191ñ.
pHá791ñ: between 3.0and 5.5,in a solution (1in 25).
Loss on drying á731ñ Dry it at 105for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ: not more than 0.1%.
Heavy metals,Method Iá231ñ Dissolve 1g in 25mLof water:the limit is 0.002%.
Sulfate á221ñ Dissolve 500mg in 40mLof water:any turbidity produced is not more than that produced in a solution containing 0.10mLof 0.020Nsulfuric acid.
Readily carbonizable substances á271ñ Dissolve 100mg in 5mLof sulfuric acid TS:the solution has no more color than Matching Fluid A.
Chromatographic purity—
Standard solutionand Standard dilutions— Prepare a solution of USP Dopamine Hydrochloride RSin methanol to contain 30mg per mL(Standard solution).Prepare a series of dilutions of the Standard solutionin methanol to contain 0.6mg,0.3mg,and 0.15mg per mL(Standard dilutions),corresponding to 2.0%,1.0%,and 0.5%of impurities,respectively.
Test solution— Transfer 150mg of Dopamine Hydrochloride to a 5-mLvolumetric flask,dilute with methanol to volume,and mix.
Procedure— In a suitable chromatographic chamber arranged for thin-layer chromatography (see Chromatography á621ñ),place a solvent system consisting of 13volumes of chloroform,9volumes of methanol,and 4volumes of dilute glacial acetic acid (3in 10).Line the chamber with filter paper,and allow to equilibrate.Apply 10-µLportions of the Standard solution,the Standard dilutions,and the Test solutionto a 20-×20-cm chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture.Develop the chromatogram until the solvent front has moved about 15cm.Remove the plate from the developing chamber,allow to dry at room temperature for several minutes,and spray evenly with a freshly prepared mixture containing equal volumes of ferric chloride solution (1in 10)and potassium ferricyanide solution (1in 20).[Dopamine and its related impurities appear as blue spots under visible light.]The Test solutionexhibits its principal spot at an RFvalue corresponding to that of the Standard solutionand not more than three secondary spots.Estimate the concentration of any secondary spots exhibited by the Test solutionby comparison with the Standard dilutions:the sum of the impurities is not greater than 1.0%.
Assay— Dissolve about 75mg of Dopamine Hydrochloride,accurately weighed,in 5mLof formic acid,add 25mLof acetic anhydride,and mix.Titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 18.96mg of C8H11NO2·HCl.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 690
Pharmacopeial Forum:Volume No.29(5)Page 1469
Phone Number:1-301-816-8305