Deslanoside Injection
»Deslanoside Injection is a sterile solution of Deslanoside in a suitable solvent.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C47H74O19.It may contain Glycerin.
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass.
Identification— Transfer a volume of Injection,equivalent to about 2mg of deslanoside,to a small separator,and extract with 25mLof a mixture of 7volumes of chloroform and 3volumes of alcohol.Transfer the extract to a 10-mLconical flask,evaporate on a steam bath to dryness,and dissolve the residue in 500µLof methanol.Proceed with a 5-µLportion of the solution so obtained,as directed in the Identificationtest under Deslanoside,beginning with “Apply 5µLof this solution.”The specified result is obtained.
pHá791ñ: between 5.5and 7.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Standard preparation— Prepare as directed in the Assayunder Deslanoside.
Assay preparation— Transfer a volume of Injection,equivalent to about 600µg of deslanoside,to a separator,and add 50mLof water and 1mLof 2Nsulfuric acid.Extract with four 30-mLportions of a mixture of 5volumes of chloroform and 1volume of n-propyl alcohol,washing each portion in a second separator containing 5mLof water and filtering through cotton that previously has been moistened with chloroform.Combine the extracts,and evaporate on a steam bath,with the aid of a current of air,just to dryness.Transfer the residue,with the aid of a small volume of the chloroform–n-propyl alcohol mixture,to a 25-mLconical flask.
Procedure— Transfer 3.0mLeach of the Standard preparationand of alcohol to provide the blank to separate 25-mLconical flasks.Using these solutions and the Assay preparation,proceed as directed for Procedurein the Assayunder Deslanoside,beginning with “Evaporate each with gentle warming.”Calculate the quantity,in µg,of C47H74O19in each mLof the Injection taken by the formula:
(C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Deslanoside RSin the Standard preparation;Vis the volume,in mL,of Injection taken;and AUand ASare the maximum absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 583
Phone Number:1-301-816-8305