Tylosin Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Tylosin Injection is a sterile solution of tylosin in a suitable vehicle. It contains NLT 85.0% and NMT 115.0% of the labeled amount of tylosin..

2 IDENTIFICATION

The retention time of the major peak for tylosin A in the Sample solution corresponds to that in the Standard solution, as obtained in the test for Content of Tylosins.

3 ASSAY

PROCEDURE

Standard: USP Tylosin RS

Analysis: Proceed as directed for Tylosin under Antibiotics-Microbial Assays (81). Prepare the Test Dilution as follows. Transfer a 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 methanol and Buffer No. 3 (1:1), and mix. This solution contains about 4 µg of tylosin/mL.

Acceptance criteria: 85.0%-115.0%

4 SPECIFIC TESTS

CONTENT OF TYLOSINS

Solution A: 184 g/L of sodium perchlorate in water.

Mobile phase: Acetonitrile and Solution A (2:3). Adjust with 1 N hydrochloric acid to a pH of 2.5 ± 0.1, and filter. [Note-Make adjustments if necessary (see System Suitability under Chromatography (621))]

Diluent: Methanol and water (1:9)

Standard solution: 0.3 mg/ml of USP Tylosin RS in Diluent

Sample solution: Dilute an accurately measured volume of Injection with Diluent to obtain a solution having a nominal concentration of 0.25 Mode: LC mg/ml.

Chromatographic system

(See Chromatography (621), System Suitability)

Mode: LC

Detector: UV 280 nm

Column: 4.6-mm × 20-cm column; 5-µm packing L1

Column temperature: 25°

Flow rate: 0.7 mL/min

Injection volume: 20 µL

Run time: 1.5 times the retention time of tylosin A peak

System suitability

Sample: Standard solution

[Note—The relative retention times in Table 1 are provided as information that aid in peak assignment.]

^a (10E,12E)-(3R,4S,5S,6R,8R,14S,15R)-14-[(6-Deoxy-2-O-methyl-β-d-allopyranosyl)oxymethyl]-5-[[3,6-dideoxy-4-O-(2,6-dideoxy-3-C-methyl-αl-ribo-hexopyranosyl)-3-dimethylamino-β-d-glucopyranosyl]oxy]-6-formylmethyl-3-hydroxy-4,8,12-trimethyl-9-oxoheptadeca-10,12-dien15-olide.

^b (10E,12E)-(3R,4S,5S,6R,8R,14S,15R)-14-[(6-Deoxy-2,3-di-O-methyl-β-d-allopyranosyl)oxymethyl]-5-[[3,6-dideoxy-3-dimethylamino-β-dglucopyranosyl]oxy]-6-formylmethyl-3-hydroxy-4,8,12-trimethyl-9-oxoheptadeca-10,12-dien-15-olide.

^c (10E,12E)-(3R,4S,5S,6R,8R,14S,15R)-14-[(6-Deoxy-2,3-di-O-methyl-β-d-allopyranosyl)oxymethyl]-5-[[3,6-dideoxy-4-O-(2,6-dideoxy-3-Cmethyl-α-l-ribo-hexopyranosyl)-3-dimethylamino-β-d-glucopyranosyl]oxy]-6-(2-hydroxyethyl)-3-hydroxy-4,8,12-trimethyl-9-oxoheptadeca10,12-dien 15-olide.

^d (10E,12E)-(3R,4S,5S,6R,8R,14S,15R)-14-[(6-Deoxy-2,3-di-O-methyl-β-d-allopyranosyl)oxymethyl]-5-[[3,6-dideoxy-4-O-(2,6-dideoxy-3-Cmethyl-α-l-ribo-hexopyranosyl)-3-dimethylamino-β-d-glucopyranosyl]oxy]-6-formylmethyl-3-hydroxy-4,8,12-trimethyl-9-oxoheptadeca10,12-dien-15 olide.

Suitability requirements

Resolution: NLT 2.8 between tylosin D and tylosin A peaks

Tailing factor: NMT 1.5 for tylosin A peak

Analysis

Samples: Sample solution

Calculate the percentages of tylosin A, tylosin B, tylosin C, and tylosin D in the portion of Injection taken:

Result = (r_u /r_T ) × 100

r_u = response of the tylosin A peak, the tylosin B peak, the tylosin C peak, or the tylosin D peak, as appropriate, from the Sample solution

r_T = sum of responses of all peaks from the Sample solution

Acceptance criteria

Content of tylosin A: NLT 75%

Sum of contents of tylosin A, tylosin B, tylosin C, and tylosin D: NLT 85%

PARTICULATE MATTER IN INJECTIONS (788): Use the procedure in Method 2-Microscopic Particle Count Test: NMT 50 particles/mL that are equal to or greater than 10 µm in effective spherical diameter are found, and NMT 5 particles/mL, that are equal to or greater than 25 µm in effective spherical diameter are found.

BACTERIAL ENDOTOXINS TEST (85): NMT 0.28 USP Endotoxin Units/mg of tylosin

STERILITY TESTS (71): Meets the requirements

Change to read:

PH (791): (ERR 1-JUN-2024) 8.0-9.5

OTHER REQUIREMENTS: It meets the requirements under Injections and Implanted Drug Products (1).

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in single-dose or multiple-dose containers, amber glass, preferably Type I or Type II, and store at a temperature not to exceed 22".

LABELING: Label it to indicate that it is for veterinary use only.

USP REFERENCE STANDARDS (11)

USP Tylosin RS