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Dextrose Excipient
» Dextrose Excipient is a sugar usually obtained by hydrolysis of starch. It contains one molecule of water of hydration.
Packaging and storage— Preserve in well-closed containers.
Labeling— Label it to indicate that it is not intended for parenteral use.
Specific rotation 781S: between +52.5 and +53.5.
Test solution: 100 mg per mL, in 0.012 N ammonium hydroxide.
Water 921 Dry it at 105 for 16 hours: it loses between 7.5% and 9.5% of its weight, determined by the Gravimetric Method.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It responds to the Identification test and meets the requirements of the tests for Color of solution, Acidity, Residue on ignition, Chloride, Sulfate, Arsenic, Heavy metals, Dextrin, and Soluble starch, sulfites under Dextrose.
Auxiliary Information— Staff Liaison : Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29–NF24 Page 3323
Phone Number : 1-301-816-8262