Ivermectin Injection
» Ivermectin Injection is a sterile solution of Ivermectin in a suitable vehicle. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of ivermectin, calculated as the sum of component H2B1a (C48H74O14) plus component H2B1b (C47H72O14). The ratio of the contents, H2B1a / (H2B1a+ H2B1b), is not less than 90.0 percent.
Packaging and storage—
Preserve in single-dose or in multi-dose containers, preferably of Type I glass or plastic. Store at a temperature of not more than 30
.
.
Labeling—
Label it to indicate that it is for veterinary use only.
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Identification—
A: Thin-Layer Chromatographic Identification Test 
201
—
201—
Test solution—
Dissolve a volume of the Injection in methanol, dilute quantitatively, and stepwise if necessary, with methanol to obtain a solution containing 0.5 mg per mL of ivermectin, and filter.
Injection volume:
2 µL.
Developing solvent system:
unsaturated chamber, consisting of a freshly prepared and equilibrated mixture of methylene chloride, methanol, and ammonium hydroxide (90:9:1).
Procedure—
Remove the plate, allow to air dry, and examine under short- and long-wavelength UV light: the retardation factor, RF , of the principal spot obtained from the Test solution corresponds to that obtained from the Standard solution.
B:
The retention times of the two principal component peaks of ivermectin in the chromatogram of the Assay preparation corresponds to that of the two principal component peaks of ivermectin in the chromatogram of the Standard preparation, obtained as directed in the Assay.
Bacterial endotoxins 85—
It contains not more than 0.016 USP Endotoxin Unit per µg of ivermectin.
85—
It contains not more than 0.016 USP Endotoxin Unit per µg of ivermectin.
Sterility 71—
It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
71—
It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Chromatographic purity—
Mobile phase and Chromatographic system—
Proceed as directed in the Assay.
Standard solution—
Dissolve an accurately weighed quantity of USP Ivermectin RS in methanol and dilute quantitatively, and stepwise if necessary, with methanol to obtain a 0.004 mg per mL solution.
Test solution—
Dissolve a volume of the Injection in methanol and dilute quantitatively, and stepwise if necessary, with methanol to obtain a solution containing 0.4 mg of ivermectin per mL of solution, based on the label claim.
Procedure—
Inject equal volumes (about 20 µL) of the Test solution and the Standard solution into the chromatograph, record the chromatograms, and measure all of the peak responses. Calculate the percentage of each impurity in the portion of Injection taken by the formula:
100(CS / CT)(ri / rS)
in which CS is the concentration, in mg per mL, of ivermectin in the Standard solution; CT is the concentration, in mg per mL, of ivermectin in the Test solution; ri is the peak response for each individual peak obtained from the Test solution; and rS is the ivermectin peak response obtained from the Standard solution. Not more than 2.7% of the peak with a relative retention time of about 1.3 to 1.5 to that of the principal peak is found; not more than 1.0% of any other impurity is found; and not more than 6.0% of total impurities is found. Disregard any peak below 0.05%.
Other requirements—
It meets the requirements under Injections 1.
1.
Assay—
Mobile phase—
Prepare a filtered and degassed mixture of acetonitrile, methanol, and water (106:55:39). Make adjustments if necessary (see System Suitability under Chromatography 621).
621).
Standard preparation—
Dissolve an accurately weighed quantity of USP Ivermectin RS in methanol and dilute quantitatively, and stepwise if necessary, with methanol to obtain a 0.4 mg per mL solution.
Assay preparation—
Dilute a volume of Injection in methanol and dilute quantitatively, and stepwise if necessary, with methanol to obtain a solution containing 0.4 mg of ivermectin per mL of solution, based on the label claim.
Chromatographic system (see Chromatography 621)—
The liquid chromatograph is equipped with 245-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between the first peak (component H2B1b) and the second peak (component H2B1a) is not less than 3.0; and the relative standard deviation for replicate injections is not more than 2.0%, determined from the component H2B1a peak.
621)—
The liquid chromatograph is equipped with 245-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between the first peak (component H2B1b) and the second peak (component H2B1a) is not less than 3.0; and the relative standard deviation for replicate injections is not more than 2.0%, determined from the component H2B1a peak.
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 component H2B1a plus component H2B1b. Calculate the percentage of label claim of ivermectin (H2B1a + H2B1b) in the portion of Injection taken by the formula:
100(CS / CU)(rU / rS)
in which CS is the concentration, in mg per mL, of USP Ivermectin RS in the Standard preparation; CU is the concentration, in mg per mL, of ivermectin in the Assay preparation; rU is the total peak response of H2B1a plus H2B1b peaks obtained from the Assay preparation; and rS is the total peak response of H2B1a plus H2B1b peaks obtained from the Standard preparation. Calculate the ratio of the contents, in percent, of H2B1a / (H2B1a + H2B1b) in the portion of Injection taken by the formula:
100(r1 / rU)
in which r1 is the peak response of H2B1a obtained from the Assay preparation; and rU is as defined above.
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 |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 3606
Pharmacopeial Forum: Volume No. 33(5) Page 913