Dinoprost Tromethamine
(dye' noe prost troe meth' a meen).
Click to View Image
C20H34O5·C4H11NO3 475.62
Prosta-5,13-dien-1-oic acid, 9,11,15-trihydroxy-, (5Z,9,11,13E,15S)-, compd. with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1).
(E,Z)-(1R,2R,3R,5S)-7-[3,5-Dihydroxy-2-[(3S)-(3-hydroxy-1-octenyl)]cyclopentyl]-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1).
Prostaglandin F2a tromethamine [38562-01-5].
» Dinoprost Tromethamine contains not less than 95.0 percent and not more than 105.0 percent of C20H34O5·C4H11NO3, calculated on the dried basis. [Caution—Great care should be taken to prevent inhaling particles of Dinoprost Tromethamine and exposing the skin to it. ]
Packaging and storage— Preserve in tight containers.
USP Reference standards 11
USP Dinoprost Tromethamine RS Click to View Structure
Specific rotation 781S: between +19 and +26.
Test solution: 20 mg per mL, in alcohol.
Loss on drying 731 Dry it in vacuum at room temperature and at a pressure not exceeding 5 mm of mercury for 16 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.5%.
Chromatographic purity— [note—Prepare solutions immediately prior to use. ]
Mobile phase— Proceed as directed in the Assay.
Standard stock solution— Prepare as directed for Standard preparation in the Assay.
Standard solution— Transfer 1.0 mL of the Standard stock solution to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Test solution— Prepare as directed for the Assay preparation.
Chromatographic system— Proceed as directed in the Assay. Chromatograph the Test solution, and record the peak responses as directed for Procedure: the resolution, R, between dinoprost tromethamine and any other adjacent peak is not less than 1.0.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the peak responses. Calculate the percentage of each impurity in the portion of Dinoprost Tromethamine taken by the formula:
2.5(C/W)F(ri / rS)
in which C is the concentration, in µg per mL, of USP Dinoprost Tromethamine RS in the Standard solution; W is the weight, in mg, of Dinoprost Tromethamine taken to prepare the Test solution; F is the relative response factor and is equal to 0.25 for any peak at a relative retention time of about 0.30, 1.7 for any peak at a relative retention time of about 1.15, and 1.0 for any other peak; ri is the peak response of each impurity obtained from the Test solution; and rS is the peak response of dinoprost tromethamine obtained from the Standard solution: not more than 2.0% of any impurity having a relative retention time of about 0.94 is found; not more than 1.5% of any impurity having a relative retention time of about 0.84 is found; not more than 0.5% of any other impurity is found; and not more than 2.0% of all other impurities is found.
Assay— [note—Prepare solutions immediately prior to use. ]
Mobile phase— Prepare a filtered and degassed mixture of water, acetonitrile, and phosphoric acid (750:250:1). Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation— Dissolve an accurately weighed quantity of USP Dinoprost Tromethamine RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 1.0 mg per mL.
Assay preparation— Transfer about 25.0 mg of Dinoprost Tromethamine, accurately weighed, to a 25-mL volumetric flask, dissolve in and dilute with Mobile phase to volume, and mix.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 200-nm detector and a 3.9-mm × 15-cm column that contains packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency is not less than 6000 theoretical plates, and the relative standard deviation for replicate injections is not more than 2.0%.
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 C20H34O5·C4H11NO3 in the portion of Dinoprost Tromethamine taken by the formula:
25C(rU / rS)
in which C is the concentration, in mg per mL, of USP Dinoprost Tromethamine 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.
Topic/Question Contact Expert Committee
Monograph Morgan Puderbaugh, B.S.
Associate Scientific Liaison
1-301-998-6833
(SM32010) Monographs - Small Molecules 3
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 2927
Pharmacopeial Forum: Volume No. 28(4) Page 1102