Dextran 70in Sodium Chloride Injection
»Dextran 70in Sodium Chloride Injection is a sterile solution of Dextran 70and Sodium Chloride 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 0.81g and not more than 0.99g of sodium chloride.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 0.04.
Identification— Quantitatively dilute a portion of Injection with sodium chloride solution (0.9in 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 times of the diluted Injection and sodium chloride solution (0.9in 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 sodium chloride solution;tand t0are the flow times for the diluted Injection and the sodium chloride 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 4.0and 7.0.
Other requirements— It meets the requirements for Injections á1ñand for Particulate Matter in Injections á788ñ.
Assay for sodium chloride— Pipet a volume of Injection,equivalent to about 90mg of chloride,into a porcelain casserole,and add 100mLof water and 1mLof dichlorofluorescein TS.Mix,and titrate with 0.1Nsilver nitrate VSuntil the silver chloride flocculates and the mixture acquires a faint pink color.Each mLof 0.1Nsilver nitrate is equivalent to 5.844mg of sodium chloride.
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 taken by the formula:
100(a/l)(1/197.5),
in which 197.5represents an average value for the specific rotation of dextran 70;ais the observed optical rotation,in degrees;and lis the length,in dm,of the polarimeter tube.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 606
Pharmacopeial Forum:Volume No.27(3)Page 2533
Phone Number:1-301-816-8339