Dextran 70 in Sodium Chloride Injection
» Dextran 70 in Sodium Chloride Injection is a sterile solution of Dextran 70 and Sodium Chloride in Water for Injection. It contains in each 100 mL not less than 5.4 g and not more than 6.6 g of dextran 70 and not less than 0.81 g and not more than 0.99 g 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 L. Where the contents are less than 100 mL, the label alternatively may state the total osmolar concentration in mOsmol per mL.
USP Reference standards 11
USP Endotoxin RS
Color of solution— Its absorbance, determined at 375 nm against a water blank, is not greater than 0.04.
Identification— Quantitatively dilute a portion of Injection with sodium chloride solution (0.9 in 100) to a concentration of about 10 mg of dextran 70 per mL. Using a capillary tube viscosimeter having dimensions such that the flow time of water is not less than 100 seconds, measure the times of the diluted Injection and sodium chloride solution (0.9 in 100) at 20. Calculate the intrinsic viscosity by the formula:
{ln[(RD)(t / t0)]} / C
in which RD is the ratio of the density of the diluted Injection to that of the sodium chloride solution; t and t0 are the flow times for the diluted Injection and the sodium chloride solution, respectively; and C is the concentration, in g per mL, of dextran 70 in the diluted Injection: the intrinsic viscosity is between 24 and 29 mL per g.
Bacterial endotoxins 85 It contains not more than 0.5 USP Endotoxin Unit per mL.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 4.0 and 7.0.
Other requirements— It meets the requirements for Injections 1 and for Particulate Matter in Injections 788.
Assay for sodium chloride— Pipet a volume of Injection, equivalent to about 90 mg of chloride, into a porcelain casserole, and add 100 mL of water and 1 mL of dichlorofluorescein TS. Mix, and titrate with 0.1 N silver nitrate VS until the silver chloride flocculates and the mixture acquires a faint pink color. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of sodium chloride.
Assay for dextran 70— To 25 mL of Injection add 1 drop of 5 N ammonium hydroxide, and mix. Determine the optical rotation (see Optical Rotation 781) in a suitable polarimeter and calculate the concentration, in g per 100 mL, of dextran 70 in the Injection taken by the formula:
100(a / l)(1 / 197.5)
in which 197.5 represents an average value for the specific rotation of dextran 70; a is the observed optical rotation, in degrees; and l is the length, in dm, of the polarimeter tube.
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Monograph Anita Y. Szajek, Ph.D.
Principal Scientific Liaison
1-301-816-8325
(BIO12010) Monographs - Biologics and Biotechnology 1
Reference Standards RS Technical Services
1-301-816-8129
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85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 2857
Pharmacopeial Forum: Volume No. 27(3) Page 2533