Dyphylline Injection
» Dyphylline Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C10H14N4O4.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass, 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 5 mL with 20 mL of water, and add 1.0 mL of 2 N sodium hydroxide and 2 drops of potassium permanganate TS: a green color is produced.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation obtained as directed in the Assay.
C: Transfer a portion of Injection, equivalent to about 100 mg of dyphylline, to a 200-mL volumetric flask, dilute with water to volume, and mix. Transfer 2 mL to a 100-mL volumetric flask, dilute with water to volume, and mix: the UV absorption spectrum of the solution exhibits maxima and minima at the same wavelengths as that of a solution of USP Dyphylline RS containing 10 µg per mL, concomitantly measured.
Bacterial endotoxins 85 It contains not more than 0.7 USP Endotoxin Unit per mg of dyphylline.
pH 791: between 5.0 and 8.0.
Other requirements— It meets the requirements under Injections 1.
Assay—
Mobile phase, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Dyphylline Tablets.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 100 mg of dyphylline, to a 500-mL volumetric flask, add water to volume, and mix.
Procedure— Proceed as directed in the Assay under Dyphylline Tablets. Calculate the quantity, in mg, of C10H14N4O4 in each mL of the Injection taken by the formula:
(0.5C / V)(rU / rS)
in which V is the volume, in mL, of Injection taken, and the other terms are as defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
1-301-816-8143
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2224
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.