Dextran 40in Dextrose Injection
»Dextran 40in Dextrose Injection is a sterile solution of Dextran 40and Dextrose in Water for Injection.It contains in each 100mLnot less than 9.0g and not more than 11.0g of Dextran 40and 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 0.06.
Identification— Dilute a portion quantitatively with dextrose solution (4.5in 100)to a concentration of about 10mg of Dextran 40per 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 that 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 40in the diluted Injection:the intrinsic viscosity is between 18and 23mLper g.
Bacterial endotoxins á85ñ— It contains not more than 1.0USP 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 3.0and 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—
Mobile phase— Use filtered and degassed 0.01Nsulfuric acid.
System suitability preparation— Prepare a solution in water containing 5mg each of dextrose and xylitol per mL.
Standard preparation— Dissolve an accurately weighed quantity of USP Dextrose RSin water to obtain a solution having a known concentration of about 5mg of dextrose monohydrate per mL.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 250mg of dextrose monohydrate,to a 50-mLvolumetric flask,dilute with water to volume,and mix.
Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a refractive index detector and a 7.8-mm ×30-cm column containing packing L17.The column and,if necessary,the detector are maintained at a constant temperature of about 40,and the flow rate is about 0.6mLper minute.Chromatograph the System suitability preparation,and measure the peak responses as directed for Procedure:the resolution,R,between the dextrose and xylitol peaks is not less than 2.5.Chromatograph the Standard preparationas directed for Procedure:the relative standard deviation for replicate injections is not more than 1.5%for dextrose.
Procedure— Inject equal volumes (about 50µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the dextrose peaks.Calculate the concentration,in g per 100mL,of dextrose monohydrate (C6H12O6·H2O)in the volume of Injection taken by the formula:
(198.17/180.16)C(rU/rS),
in which Cis the concentration,in g per 100mL,of USP Dextrose RSin the Standard preparation;and rUand rSare the peak areas obtained from the Assay preparationand the Standard preparation,respectively.
Assay for dextran 40— To 25mLof Injection add 1drop of 5Nammonium hydroxide,and mix.Determine the optical rotation (see Optical Rotation á781ñ),and calculate the concentration,in g per 100mL,of Dextran 40in the Injection taken by the formula:
(1/197.5)[(100a/l)-(52.75Cd)],
in which 197.5and 52.75represent average values for the specific rotation of Dextran 40and dextrose,respectively;ais the observed optical rotation in degrees;lis the length,in dm,of the polarimeter tube;and Cdis the concentration,in g per 100mL,of dextrose as determined in the Assay for dextrose.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 604
Phone Number:1-301-816-8339