Dopamine Hydrochloride and Dextrose Injection
»Dopamine Hydrochloride and Dextrose Injection is a sterile solution of Dopamine Hydrochloride and Dextrose in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of dopamine hydrochloride (C8H11NO2·HCl)and of dextrose (C6H12O6·H2O).
NOTE—Do not use the Injection if it is darker than slightly yellow or discolored in any other way.
Packaging and storage— Preserve in single-dose glass or plastic containers.Glass containers are preferably of Type Ior Type IIglass.
Labeling— The label states the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,or where the label states that the Injection is not for direct injection but is to be diluted before use,the label alternatively may state the total osmolar concentration in mOsm per mL.
Identification—
A: It responds to the Identificationtest under Dextrose.
B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay for dopamine hydrochloride.
Bacterial endotoxins á85ñ— It contains not more than 16.67USP Endotoxin Units per mg of dopamine hydrochloride.
pHá791ñ: between 2.5and 4.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Limit of 5-hydroxymethylfurfural and related substances—
Diluting solution— Prepare a solution containing approximately 0.022Nsodium hydroxide in water.
Cation-exchange column— Proceed as directed under Column Partition Chromatography(see Chromatography á621ñ),using a chromatographic tube capable of providing a 0.8-cm ×4-cm bed volume (or about 2mL)of 100-to 200-mesh,strongly acidic,styrene-divinylbenzene cation-exchange resin.Condition the column by washing with about 30mLof water,discarding the eluate.
Procedure— Pass a volume of Injection containing about 100mg of hydrous dextrose through the resin bed in the Cation-exchange column,allowing the specimen to flow down the wall of the column so as not to disturb the resin bed,and collect the eluate in a 50-mLvolumetric flask.Wash the column with 25mLof water,and collect the eluate in the same 50-mLvolumetric flask.Dilute the eluate with Diluting solutionto volume,and mix to obtain the test solution.In a similar manner,prepare a blank by passing 27mLof water through a freshly conditioned Cation-exchange column,collecting the eluate in a 50-mLvolumetric flask,diluting with Diluting solutionto volume,and mixing.Determine the absorbance of the test solution against the blank in a 1-cm cell at 284nm,with a suitable spectrophotometer:the absorbance is not more than 0.25.
Other requirements— It meets the requirements under Injections á1ñ.
Assay for dopamine hydrochloride— Proceed with Injection as directed in the Assayunder Dopamine Hydrochloride Injection.
Assay for dextrose— Transfer an accurately measured volume of Injection,containing 2to 5g of dextrose,to a 100-mLvolumetric flask.Add 0.2mLof 6Nammonium hydroxide,dilute with water to volume,and mix.Determine the angular rotation in a suitable polarimeter tube at 25(see Optical Rotation á781ñ).The observed rotation,in degrees,multiplied by 1.0425A,in which Ais the ratio 200divided by the length,in mm,of the polarimeter tube employed,represents the weight,in g,of C6H12O6·H2Oin the volume of Injection taken.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 691
Pharmacopeial Forum:Volume No.30(5)Page 1615
Phone Number:1-301-816-8305