Dextrose and Sodium Chloride Injection
»Dextrose and Sodium Chloride Injection is a sterile solution of Dextrose and Sodium Chloride in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of C6H12O6·H2Oand of NaCl.It contains no antimicrobial agents.
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 mOsmol per mL.
Identification— It responds to the Identificationtest under Dextrose,and to the tests for Sodium á191ñand for Chloride á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 10.0USP Endotoxin Units per g of dextrose.
pHá791ñ: between 3.2and 6.5,determined on a portion diluted with water,if necessary,to a concentration of not more than 5%of dextrose.
Limit of 5-hydroxymethylfurfural and related substances— Dilute an accurately measured volume of Injection,equivalent to 1.0g of C6H12O6·H2Owith water to 500.0mL.Determine the absorbance of this solution in a 1-cm cell at 284nm,with a suitable spectrophotometer,using water as the blank:the absorbance is not more than 0.25.
Other requirements— It meets the requirements under Injections á1ñ.
Assay for dextrose— Transfer an accurately measured volume of Injection,containing from 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.
Assay for sodium chloride— Transfer an accurately measured volume of Injection,equivalent to about 90mg of sodium chloride,to a conical flask,and add 10mLof glacial acetic acid,75mLof methanol,and 3drops of eosin Y TS.Titrate,with shaking,with 0.1Nsilver nitrate VSto a pink endpoint.Each mLof 0.1Nsilver nitrate is equivalent to 5.844mg of NaCl.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 612
Pharmacopeial Forum:Volume No.30(5)Page 1614
Phone Number:1-301-816-8379