(kloe prost' e nol soe' dee um).
5-Heptenoic acid, 7-[2-[4-(3-chlorophenoxy)-3-hydroxy-1-butenyl]-3,5-dihydroxycyclopentyl]-, [1(Z),2(1E,3R*),3,5]-, sodium salt, (±)-.
(±)-Sodium (Z)-7-[(1R*,2R*,3R*,5S*)-2-[(E)-(3R*)-4-(m-chlorophenoxy)-3-hydroxy-1-butenyl]-3,5-dihydroxycyclopentyl]-5-heptenoate [55028-72-3].
» Cloprostenol Sodium contains not less than 97.5 percent and not more than 102.5 percent of C22H28ClNaO6, calculated on the anhydrous basis.
Packaging and storage Preserve in tight, light-resistant containers.
Labeling Label it to indicate that it is for veterinary use only.
USP Reference standards 11
B: It meets the requirements of the test for Sodium 191.
Water, Method I 921 Use 50 mg dissolved in 1 mL of dehydrated alcohol: not more than 3.0%.
Mobile phase Prepare a filtered and degassed mixture of the chromatographic solvent hexane, dehydrated alcohol, and glacial acetic acid (930:70:1). Make adjustments if necessary (see System Suitability under Chromatography 621).
Test solution Dissolve an accurately weighed quantity of Cloprostenol Sodium in dehydrated alcohol, and dilute quantitatively, and stepwise if necessary, with dehydrated alcohol to obtain a solution having a known concentration of about 20 mg per mL.
Chromatographic system (see Chromatography 621) Prepare as directed in the Assay.
Procedure Inject a volume (about 5 µL) of the Test solution into the chromatograph. Record the chromatogram for a total time of not less than twice the retention time of the peak due to cloprostenol, and measure all of the peak responses. Calculate the percentage of each impurity in the portion of Cloprostenol Sodium 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 2.5% of total impurities is found. Disregard any peak below 0.05%.
Mobile phase Prepare a filtered and degassed mixture of the chromatographic solvent hexane, dehydrated alcohol, and glacial acetic acid (900:100:1). Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation Dissolve an accurately weighed quantity of USP Cloprostenol Sodium RS in dehydrated alcohol, and dilute quantitatively, and stepwise if necessary, with dehydrated alcohol to obtain a solution having a known concentration of about 0.8 mg per mL.
Assay preparation Using a suitable quantity of Cloprostenol Sodium, accurately weighed, proceed as directed in the Standard preparation.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 220-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L3. The flow rate is about 1.8 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the tailing factor is not more than 1.5 for the cloprostenol peak; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure Separately inject equal volumes (about 5 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 percentage of C22H28ClNaO6 in the portion of Cloprostenol Sodium taken by the formula:
100(CS / CU)(rU / rS)in which CS is the concentration, in mg per mL, of USP Cloprostenol RS in the Standard preparation; CU is the concentration, in mg per mL, of Cloprostenol Sodium in the Assay preparation; and rU and rS are the cloprostenol peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2736Pharmacopeial Forum: Volume No. 34(4) Page 920