Pyrantel Tartrate

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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C₁₁H₁₄N₂S.C₄H₁₆O₆ 356.39 

Pyrimidine, 1,4,5,6-tetrahydro-1-methyl-2-[2-(2-thienyl)ethenyl]-, (E)-, (2R,3R)-2,3-dihydroxybutanedioate (1:1); (E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl)vinyl]pyrimidine tartrate (1:1) CAS RN®: 33401-94-4; UNII: SC82VF0480. 

1 DEFINITION 

Pyrantel Tartrate contains NLT 98.0% and NMT 102.0% of pyrantel tartrate (C₁₁H₁₄N₂S.C₄H₁₆O₆), calculated on the dried basis.

2 IDENTIFICATION

Change to read: 

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

[Note—Concomitantly prepare potassium bromide dispersions of the Standard and sample. Differences between sets of Standard/sample spectra may occur as a result of differing specimen preparation or environmental conditions.] 

B. Identification Tests—General, Tartrate 〈191〉 

C. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. 

3 ASSAY 

Procedure 

[Note—Protect all solutions containing Pyrantel Tartrate from light.] 

Mobile phase: Acetonitrile, glacial acetic acid, diethylamine, and water (94:2.5:1:2.5) 

Standard solution: 0.42 mg/mL of USP Pyrantel Tartrate RS in Mobile phase 

Sample solution: 0.42 mg/mL of Pyrantel Tartrate in Mobile phase 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 316 nm 

Column: 4.6-mm × 25-cm; 5-µm packing L3 

Flow rate: 1 mL/min 

Injection volume: 5 µL 

System suitability 

Sample: Standard solution 

Suitability requirements 

Tailing factor: NMT 1.5 

Relative standard deviation: NMT 0.73% 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of pyrantel tartrate (C₁₁H₁₄N₂S.C₄H₁₆O₆) in the portion of Pyrantel Tartrate taken:

Result = (r_U/r_S) × (C_S/C_U) × 100 

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Pyrantel Tartrate RS in the Standard solution (mg/mL)

C_U = concentration of Pyrantel Tartrate in the Sample solution (mg/mL)

Acceptance criteria: 98.0%–102.0% on the dried basis 

4 IMPURITIES 

Residue on Ignition 〈281〉: NMT 0.1% 

Organic Impurities 

[Note—Protect all solutions containing Pyrantel Tartrate from light.] 

Mobile phase: Acetonitrile, glacial acetic acid, diethylamine, and water (94:2.5:1:2.5) 

Standard solution: 0.84 µg/mL of USP Pyrantel Tartrate RS in Mobile phase 

Sample solution: 0.42 mg/mL of Pyrantel Tartrate in Mobile phase 

System suitability solution: Expose a portion of the Sample solution to short-wavelength UV light for 30 min (Pyrantel Tartrate undergoes partial degradation to cis-pyrantel). A degradation level to at least 0.3% of cis-pyrantel must be obtained, as shown by the appearance of a corresponding peak in the chromatogram. If it is not obtained, again expose the solution to short-wavelength UV light. Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 236 and 316 nm 

Column: 4.6-mm × 25-cm; 5-µm packing L3 

Flow rate: 1 mL/min 

Run time: 2.5 times the retention time of pyrantel 

Injection volume: 100 µL 

System suitability 

Sample: System suitability solution 

[Note—The relative retention times for pyrantel and cis-pyrantel are 1.0 and 1.2, respectively.] 

Suitability requirements 

System suitability requirements must be met at both 236 and 316 nm. 

Resolution: NLT 1.5 between pyrantel and cis-pyrantel 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of each impurity detected at 236 nm in the portion of Pyrantel Tartrate taken: 

Result = (r_U/r_S) × (C_S/C_U) × 100 

r_U = peak response of each individual impurity detected at 236 nm from the Sample solution

r_S = peak response detected at 236 nm from the Standard solution

C_S = concentration of the Standard solution (µg/mL) 

C_U = concentration of the Sample solution (µg/mL)

Calculate the percentage of each impurity detected at 236 nm in the portion of Pyrantel Tartrate taken: 

Result = (r_U/r_S) × (C_S/C_U) × 100 

r_U = peak response of each individual impurity detected at 316 nm from the Sample solution

r_S = peak response detected at 316 nm from the Standard solution

C_S = concentration of the Standard solution (µg/mL) 

C_U = concentration of the Sample solution (µg/mL)

Acceptance criteria 

Any individual impurity: NMT 0.2% of any individual impurity detected at 236 nm; NMT 0.2% of any individual impurity detected at 316 nm

Total impurities: NMT 1.0% of total impurities detected at 236 nm; NMT 1.0% of total impurities detected at 316 nm 

5 SPECIFIC TESTS 

pH 〈791〉 

Sample solution: 10.0 mg/mL in carbon dioxide-free water 

Acceptance criteria: 3.3–3.7 

Loss on Drying 〈731〉 

Analysis: Dry at 105° for 4 h. 

Acceptance criteria: NMT 1.0% 

6 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in well-closed containers protected from light, and store at room temperature. 

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

USP Reference Standards 〈11〉 

USP Pyrantel Tartrate RS