Ivermectin and Clorsulon Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Ivermectin and Clorsulon Injection is a sterile solution of Ivermectin and Clorsulon in a suitable vehicle. It contains not less than 95.0 percent and not more than 110.0 percent of the labeled amount of ivermectin [component B1a (C48H74O14) plus component B1b (C47H72O14)] and not less than 95.0 percent and not more than 105.0 percent of the labeled amount of clorsulon (C8H8Cl3N3O4S2).
Packaging and storage—Preserve in single-dose or multi-dose containers, preferably of Type I glass or plastic. Store at a temperature not higher than 30°.
Labeling—Label it to indicate that it is for veterinary use only.
USP Reference standards 〈11〉—
USP Clorsulon RS
USP Ivermectin RS
Identification—
A: Thin-Layer Chromatographic Identification Test 〈201〉—
Test solution: about 0.5 mg of ivermectin and 5 mg of clorsulon per mL in methanol.
Application volume: 2 μL.
Developing solvent system: a mixture of methylene chloride, methanol, and ammonium hydroxide (90:9:1).
B: The retention times of the two major peaks in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay for ivermectin. The retention time of the major clorsulon peak in the chromatogram of the
Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay for clorsulon.
[Note—The two major ivermectin components are not separated by this method.]
Bacterial Endotoxins Test 〈85〉 —It contains not more than 2.3 USP Endotoxin Units per mg of combined ivermectin and clorsulon.
Sterility Tests 〈71〉 : meets the requirements.
Other requirements—It meets the requirements under Injections and Implanted Drug Products 〈1〉.
Assay for ivermectin—
Mobile phase—Prepare a
filtered and degassed mixture of acetonitrile, methanol, and water (530:350:70). Make adjustments if necessary (see System Suitability under Chromatography 〈621〉). Increasing the proportion of water increases the resolution.
Standard preparation—Prepare a solution of USP Ivermectin RS in methanol having a known concentration of about 0.3 mg per mL.
Assay preparation—Transfer an accurately measured portion of Injection, equivalent to about 30 mg of ivermectin, to a 100-mL volumetric flask, dissolve in and dilute with methanol to volume, and mix.
Chromatographic system (see Chromatography 〈621〉)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains 5-μm packing L1. The flow rate is about 1.2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure [Note—The relative retention times are about 0.8 for component B1b and 1.0 for component B1a.]: the resolution, R, between component B and component B1b is not less than 2.0; the column effciency determined from the component B peak is not less than 2000 theoretical plates; and the relative standard deviation for replicate injections determined for the component B1a peak is not more than 1.0%.
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 area responses for the major peaks. Calculate the quantity, in mg, of ivermectin component B1a (C48H74O14) plus ivermectin component B1b (C47H72O14)] in the portion of Injection taken by the formula:
CP(rU/rS )
in which C is the concentration, in mg per mL, of USP Ivermectin RS in the Standard preparation; P is the designated percentage of the sum of component B1a plus component B1b in USP Ivermectin RS; and rU and rSare the sums of the peak area responses for ivermectin component B1a plus ivermectin component B1b obtained from the Assay preparation and the Standard preparation, respectively.
Assay for clorsulon—
Mobile phase—Prepare a filtered and degassed mixture of chloroform, methanol, and water (900:100:1). Make adjustments if necessary (see
System Suitability under Chromatography 〈621〉).
Standard preparation—Prepare a solution of USP Clorsulon RS in methanol having a known concentration of about 2.4 mg per mL. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with chloroform to volume, and mix.
Assay preparation—Transfer an accurately measured portion of Injection, equivalent to about 240 mg of clorsulon, to a 100-mL volumetric flask, dilute with methanol to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with chloroform to volume, and mix.
Chromatographic system (see Chromatography 〈621〉)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains 5-μm packing L3. The flow rate is about 0.8 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure [Note—The relative retention times are about 0.6 for ivermectin (the major components of ivermectin co-elute) and 1.0 for clorsulon.]: the column effciency determined from the clorsulon peak is not less than 4000 theoretical plates; the tailing factor for the clorsulon peak is not more than 2.0; and the relative standard deviation for replicate injections determined for the clorsulon peak is not more than 1.0%.
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 area responses for the major peaks. Calculate the quantity, in mg, of clorsulon (C8H8Cl3N3O4S2 ) in the portion of Injection taken by the formula:
1000C(rU/rS )
in which C is the concentration, in mg per mL, of USP Clorsulon RS in the Standard preparation; and rU and rS are the clorsulon peak area responses obtained from the Assay preparation and the Standard preparation, respectively.
