» Gadodiamide Injection is a sterile solution of Gadodiamide in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of gadodiamide (C16H26GdN5O8). It may contain stabilizers and buffers. Gadodiamide Injection intended for intravascular use contains no antimicrobial agents.
Packaging and storage Preserve in single-dose Containers for Injections as described under Injections 1, of Type I glass, protected from light. Store at controlled room temperature.
Labeling Label containers of Injection to direct the user to discard any unused portion.
USP Reference standards 11
USP Endotoxin RS.
USP Gadodiamide RS.
USP Gadodiamide Related Compound A RS.
USP Gadodiamide Related Compound B RS.
A: Ultraviolet Absorption 197U
Solution: 57 mg of gadodiamide per mL.
Spectral range: 240 to 300 nm.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85 It contains not more than 0.029 USP Endotoxin Unit per mg of gadodiamide.
pH 791: between 5.5 and 7.0.
Osmolarity 785: between 650 and 1000 mOsmol per kg.
Mobile phase, Postcolumn reagent, System suitability solution, and Chromatographic system Proceed as directed for Related compounds under Gadodiamide.
Test solution Transfer an accurately measured volume of Injection, equivalent to about 200 mg of gadodiamide, to a 100-mL volumetric flask, dilute with water to volume, and mix.
Procedure Inject about 10 µL of the Test solution into the chromatograph, record the chromatogram, and measure the peak responses. [noteThe tail of the gadodiamide peak may contain a small shoulder due to an isomer; the area of the shoulder should be included in the gadodiamide peak area.] Calculate the percentage of each impurity in the volume of Injection taken by the formula:
100(ri / rs)in which ri is the peak response of each impurity; and rs is the sum of all peaks having a percentage greater than 0.10%: not more than 2.0% of gadodiamide related compounds A and B is found; no individual impurity is more than 0.2%; and the sum of all impurities, other than gadodiamide related compounds A and B, is not more than 0.5%.
Other requirements It meets the requirements under Injections 1.
Mobile phase, Postcolumn reagent, and Chromatographic system Proceed as directed in the Assay under Gadodiamide.
Standard preparation Transfer about 60 mg of USP Gadodiamide RS, accurately weighed, to a 50-mL volumetric flask, dissolve in and dilute with water to volume, and mix. Transfer 15.0 mL of this solution to a 100-mL volumetric flask, dilute with water to volume, and mix.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 574 mg of gadodiamide, to a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer 3.0 mL of this solution to a 100-mL volumetric flask, dilute with water to volume, and mix.
Procedure Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of gadodiamide (C16H26GdN5O8) in each mL of the Injection taken by the formula:
(10,000/3)(C/V)(rU / rS)in which C is the concentration, in mg per mL, of USP Gadodiamide RS in the Standard preparation; V is the volume, in mL, of Injection taken; and rU and rS are the gadodiamide peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 2469Pharmacopeial Forum: Volume No. 27(2) Page 2163
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.