Dyphylline Injection
»Dyphylline Injection contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C10H14N4O4.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.To avoid precipitation,store at a temperature of not below 15,but avoid excessive heat.
Labeling— Label it to indicate that the Injection is not to be used if crystals have separated.
Identification—
A: Dilute about 5mLwith 20mLof water,and add 1.0mLof 2Nsodium hydroxide and 2drops of potassium permanganate TS:a green color is produced.
B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparationobtained as directed in the Assay.
C: Transfer a portion of Injection,equivalent to about 100mg of dyphylline,to a 200-mLvolumetric flask,dilute with water to volume,and mix.Transfer 2mLto a 100-mLvolumetric flask,dilute with water to volume,and mix:the UVabsorption spectrum of the solution exhibits maxima and minima at the same wavelengths as that of a solution of USP Dyphylline RScontaining 10µg per mL,concomitantly measured.
Bacterial endotoxins á85ñ— It contains not more than 0.7USP Endotoxin Unit per mg of dyphylline.
pHá791ñ: between 5.0and 8.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Standard preparation,andChromatographic system— Prepare as directed in the Assayunder Dyphylline Tablets.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 100mg of dyphylline,to a 500-mLvolumetric flask,add water to volume,and mix.
Procedure— Proceed as directed in the Assayunder Dyphylline Tablets.Calculate the quantity,in mg,of C10H14N4O4in each mLof the Injection taken by the formula:
(0.5C/V)(rU/rS),
in which Vis the volume,in mL,of Injection taken,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 709
Phone Number:1-301-816-8379