Dobutamine in Dextrose Injection
» Dobutamine in Dextrose Injection is a sterile solution of Dobutamine Hydrochloride and Dextrose in Water for Injection. It contains an amount of Dobutamine Hydrochloride equivalent to not less than 90.0 percent and not more than 110.0 percent of the labeled amount of dobutamine (C18H23NO3) and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of dextrose (C6H12O6·H2O). It may contain one or more suitable antioxidants or chelating agents.
Packaging and storage
Preserve in single-dose containers, preferably of Type II glass, or of a suitable plastic material, and store at room temperature, avoid excessive heat, and protect from freezing.
Labeling
The label states the total osmolar concentration in mOsmol per L.
Identification
A:
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 5.56 USP Endotoxin Units per mg of dobutamine.
pH 791:
between 2.5 and 5.5.
Particulate matter 788
It meets the requirements for large-volume injections.
Chromatographic purity
Phosphate buffer, Mobile phase, Standard preparation, System suitability solution, and Chromatographic system
Proceed as directed in the Assay under Dobutamine Hydrochloride.
Test solution
Transfer an accurately measured portion of Dobutamine in Dextrose Injection, equivalent to about 44.6 mg of dobutamine to a 100-mL volumetric flask, dilute with water to volume, and mix.
Procedure
Inject a volume (about 20 µL) of the Test solution into the chromatograph, record the chromatograms, and measure the peak responses. Calculate the percentage of each impurity, excluding 5-hydroxymethylfurfural from all calculations, in the portion of Dobutamine in Dextrose Injection taken by the formula:
100(ri / rs)
in which ri is the peak response for each impurity; and rs is the sum of the responses of all of the peaks: not more than 1.0% of any individual impurity is found, and not more than 2.0% of the total impurities is found.
Limit of 5-hydroxymethylfurfural
Ion-exchange column
Fill an 8-mm chromatographic tube to a height of about 40 mm with a 100- to 200-mesh, strongly acidic, styrene-divinylbenzene cation-exchange resin. Wash the column with about 30 mL of water, discarding the eluate. [notePrepare a new column for each Test solution and Blank solution, and use each column only once.]
Test solution
Transfer 2 mL of Injection to the ion-exchange column, and collect the eluate in a 50-mL volumetric flask. Pass 25 mL of water through the column, and collect the eluate in the same volumetric flask. Dilute the eluate with water to volume, and mix. Remove the stopper from the flask, and allow the solution to stand for about 30 minutes in order to oxidize any bisulfite ions present. The solution so obtained is the Test solution.
Blank solution
Prepare a Blank solution in a similar manner to the Test solution by passing 27 mL of water through an ion-exchange column, and collecting the eluate in a 50-mL volumetric flask. Dilute with water to volume, and mix.
Procedure
Determine the absorbance of the Test solution in a 1-cm cell at 284 nm, with a suitable spectrophotometer, after correcting for the Blank solution: the absorbance is not more than 0.25.
Other requirements
It meets the requirements under Injections 1.
Assay for dextrose
Determine the angular rotation of Injection (see Optical Rotation 781). Calculate the percentage (g per 100 mL) of dextrose (C6H12O6·H2O) in the portion of Injection taken by the formula:
(100/52.9)(198.17/180.16)AR
in which 100 is the percentage; 52.9 is the midpoint of the specific rotation range for anhydrous dextrose, in degrees; 198.17 and 180.16 are the molecular weights for dextrose monohydrate and anhydrous dextrose, respectively; A is 100 mm divided by the length of the polarimeter tube, in mm; and R is the observed rotation, in degrees.
Assay for dobutamine
Phosphate buffer, Mobile phase, Standard preparation, System suitability solution, and Chromatographic system
Proceed as directed in the Assay under Dobutamine Hydrochloride.
Assay preparation
Transfer an amount of Dobutamine in Dextrose Injection, equivalent to about 44.6 mg of dobutamine, accurately weighed, to a 100-mL volumetric flask, dilute with water to volume, and mix. [noteRefrigerate until injected, and use within 8 hours.]
Procedure
Separately inject equal volumes (about 20 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 dobutamine (C18H23NO3) in the portion of Dobutamine in Dextrose Injection taken by the formula:
(301.39/337.84)100C(rU / rS)
in which 301.39 and 337.84 are the molecular weights of dobutamine and dobutamine hydrochloride, respectively; C is the concentration, in mg per mL, of USP Dobutamine Hydrochloride RS in the Standard preparation; and rU and rS are the 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 2191
Pharmacopeial Forum: Volume No. 30(5) Page 1615
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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