Dextran 70in Dextrose Injection
»Dextran 70in Dextrose Injection is a sterile solution of Dextran 70and Dextrose in Water for Injection.It contains in each 100mLnot less than 5.4g and not more than 6.6g of dextran 70and not less than 4.1g and not more than 5.0g of dextrose (C6H12O6).It contains no bacteriostatic agents.
Packaging and storage— Preserve in single-dose glass or plastic containers.
Labeling— The label states the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,the label alternatively may state the total osmolar concentration in mOsmol per mL.
Color of solution— Its absorbance,determined at 375nm against a water blank,is not greater than 0.05.
Identification— Dilute a portion quantitatively with dextrose solution (4.5in 100)to a concentration of about 10mg of dextran 70per mL.Using a capillary tube viscosimeter having dimensions such that the flow time of water is not less than 100seconds,measure the flow times of the diluted Injection and of a dextrose solution (4.5in 100)at 20.Calculate the intrinsic viscosity by the formula:
{ln[(RD)(t/t0)]}/C,
in which RDis the ratio of the density of the diluted Injection to that of the dextrose solution;tand t0are the flow times for the diluted Injection and the dextrose solution,respectively;and Cis the concentration,in g per mL,of dextran 70in the diluted Injection:the intrinsic viscosity is between 24and 29mLper g.
Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mL.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 3.5and 7.0.
Limit of 5-hydroxymethylfurfural and related substances— Dilute an accurately measured volume of Injection,equivalent to 1.0g of C6H12O6·H2O,with water to 500.0mL.Determine the absorbance of this solution in a 1-cm cell at 284nm,using water as the blank:the absorbance is not more than 0.25.
Other requirements— It meets the requirements for Injections á1ñand for Particulate Matter in Injections á788ñ.
Assay for dextrose— Proceed as directed in the Assay for dextroseunder Dextran 40in Dextrose Injectionexcept that the Assay preparationfor Dextran 70in Dextrose Injection is obtained by dilution with water (10mLin 25mLof water).Adjust the calculations of the dextrose content to take into consideration the dilution factor.
Assay for dextran 70— To 25mLof Injection add 1drop of 5Nammonium hydroxide,and mix.Determine the optical rotation (see Optical Rotation á781ñ)in a suitable polarimeter and calculate the concentration,in g per 100mL,of dextran 70in the Injection by the formula:
(1/197.5)[(100a/l)-(52.75Cd)],
in which 197.5and 52.75represent average values for the specific rotation of dextran 70and dextrose,respectively,ais the observed optical rotation in degrees,lis the length,in dm,of the polarimeter tube,and Cdis the concentration of dextrose,in g per 100mL,from the Assay for dextrose.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 605
Phone Number:1-301-816-8339