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 á781Sñ:
between +52.5
and +53.5.
and +53.5.
Test solution:
100mg per mL,in 0.012Nammonium hydroxide.
Water á921ñ—
Dry it at 105for 16hours:it loses between 7.5%and 9.5%of its weight,determined by the Gravimetric Method.
for 16hours:it loses between 7.5%and 9.5%of its weight,determined by the Gravimetric Method.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Other requirements—
It responds to the Identificationtest and meets the requirements of the tests for Color of solution,Acidity,Residue on ignition,Chloride,Sulfate,Arsenic,Heavy metals,Dextrin,and Soluble starch,sulfitesunder Dextrose.
Auxiliary Information—
Staff Liaison:Justin Lane,B.S.,Scientific Associate
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 2996
Phone Number:1-301-816-8323