Tylosin Injection
» Tylosin Injection is a sterile solution of tylosin in a suitable vehicle. It contains not less than 85.0 percent and not more than 115.0 percent of the labeled amount of tylosin.
Packaging and storage—
Preserve in single-dose or multiple-dose containers, Type I or Type II amber glass, and store at a temperature not to exceed 22
.
.
Labeling—
Label to indicate that it is for veterinary use only.
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Identification—
The retention time of the major peak for tylosin A in the chromatogram of the Test solution corresponds to the major peak for tylosin A in the chromatogram of the Standard solution, as obtained in the test for Content of tylosins.
Bacterial endotoxins 
85
—
It contains no more than 0.28 USP Endotoxin Unit per mg of tylosin.
85—
It contains no more than 0.28 USP Endotoxin Unit per mg of tylosin.
Sterility 71:
meets the requirements.
71:
meets the requirements.
pH 791:
between 8.0 and 9.5.
791:
between 8.0 and 9.5.
Particulate matter 788—
Use the procedure in Method 2—Microscopic Particle Count Test: not more than 50 particles per mL that are equal to or greater than 10 µm in effective spherical diameter are found, and not more than 5 particles per mL that are equal to or greater than 25 µm in effective spherical diameter are found.
788—
Use the procedure in Method 2—Microscopic Particle Count Test: not more than 50 particles per mL that are equal to or greater than 10 µm in effective spherical diameter are found, and not more than 5 particles per mL that are equal to or greater than 25 µm in effective spherical diameter are found.
Content of tylosins—
Sodium perchlorate solution—
Prepare a 184 g per L solution.
Mobile phase—
Prepare a mixture of Sodium perchlorate solution and acetonitrile (3:2). Adjust with 1 N hydrochloric acid to a pH of 2.5 ± 0.1, and filter. Make adjustments if necessary (see System Suitability under Chromatography 621).
621).
Diluent—
Prepare a mixture of methanol and water (1:9).
Standard solution—
Dissolve an accurately weighed quantity of USP Tylosin RS in Diluent to obtain a solution having a known concentration of about 0.3 mg per mL.
Test solution—
Dilute an accurately measured volume of Injection with Diluent to obtain a solution having a known concentration of about 0.25 mg per mL.
Chromatographic system (see Chromatography 621)—
The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 20-cm column that contains 5-µm packing L1. The flow rate is about 0.7 mL per minute. The column temperature is maintained at 25. Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the order of elution is tylosin C, tylosin B, tylosin D, and tylosin A, with relative retention times of about 0.5, 0.6, 0.8, and 1.0 minutes, respectively; the resolution, R, of the peaks for tylosin D and tylosin A is not less than 2.8; and the tailing factor for the tylosin A peak is not more than 1.5.
621)—
The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 20-cm column that contains 5-µm packing L1. The flow rate is about 0.7 mL per minute. The column temperature is maintained at 25. Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the order of elution is tylosin C, tylosin B, tylosin D, and tylosin A, with relative retention times of about 0.5, 0.6, 0.8, and 1.0 minutes, respectively; the resolution, R, of the peaks for tylosin D and tylosin A is not less than 2.8; and the tailing factor for the tylosin A peak is not more than 1.5.
Procedure—
Separately inject equal volumes (about 20 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms over a period equivalent to 1.5 times the elution time of the main tylosin A peak, and measure all the peak areas. Calculate the percentages of tylosin A, tylosin B, tylosin C, and tylosin D in the portion of Injection taken by the formula:
100(ri / rs)
in which ri is the area of the tylosin A peak, the tylosin B peak, the tylosin C peak, or the tylosin D peak, as appropriate, in the chromatogram obtained from the Test solution; and rs is the sum of the areas of all the peaks in the chromatogram obtained from the Test solution: the content of tylosin A is not less than 75%; and the sum of the contents of tylosin A, tylosin B, tylosin C, and tylosin D is not less than 85%.
Other requirements—
It meets the requirements under Injections 1.
1.
Assay—
Proceed as directed for Tylosin under Antibiotics—Microbial Assays 81. Prepare the Test Dilution as follows. Transfer an accurately measured volume of Injection, equivalent to about 250 mg of tylosin, to a 500-mL volumetric flask, add 50 mL of methanol, and swirl to dissolve. Dilute with Buffer No. 3 to volume, and mix. Transfer 4.0 mL of this solution to a second 500-mL volumetric flask, dilute with a mixture of Buffer No. 3 and methanol (1:1), and mix. This solution contains about 4 µg of tylosin per mL.
81. Prepare the Test Dilution as follows. Transfer an accurately measured volume of Injection, equivalent to about 250 mg of tylosin, to a 500-mL volumetric flask, add 50 mL of methanol, and swirl to dissolve. Dilute with Buffer No. 3 to volume, and mix. Transfer 4.0 mL of this solution to a second 500-mL volumetric flask, dilute with a mixture of Buffer No. 3 and methanol (1:1), and mix. This solution contains about 4 µg of tylosin per mL.
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 4974
Pharmacopeial Forum: Volume No. 34(5) Page 1205