Chloramphenicol Compounded Oral Suspension, Veterinary

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 

Chloramphenicol Compounded Oral Suspension, Veterinary contains NLT 90.0% and NMT 120.0% of the labeled amount of chloramphenicol (C₁₁H₁₂Cl₂N₂O₅).

Prepare Chloramphenicol Compounded Oral Suspension, Veterinary 200 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉). 

^a Chloramphenicol 1-g tablets, Bimeda, Inc., Le Seuer, MN. 

^b Perrigo, Allegan, MI. 

Place the Chloramphenicol tablets in a suitable container and cover with Purified Water. Allow the tablets to soak for 15–20 min. Add 30 mL of Ora-Blend and triturate to a smooth paste. Add a sufficient amount of Ora-Blend to make the contents pourable. Transfer contents stepwise and quantitatively to a calibrated container using the remainder of the Ora-Blend. Add sufficient Ora-Blend to bring to nal volume. Shake to mix well. 

2 ASSAY 

Procedure 

Solution A: Mix 500 mL of methanol and 600 mL of water. Add 1 mL of glacial acetic acid. 

Solution B: Add 0.5 mL of glacial acetic acid to 500 mL of methanol. 

Mobile phase: See Table 1. 

Table 1 

Standard solution: Transfer 20 mg of USP Chloramphenicol RS into a 200-mL volumetric flask. Add approximately 160 mL of Solution A, sonicate for 5 min, then dilute with Solution A to volume. 

Sample solution: Transfer 1 mL of Oral Suspension, Veterinary into a 200-mL volumetric flask. Add approximately 160 mL of Solution A, sonicate for 15 min, then dilute with Solution A to volume. Transfer 1 mL of this solution into a 10-mL volumetric flask. Dilute with Solution A to volume. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 280 nm 

Column: 4.6-mm × 15-cm; 5-µm packing L1 

Temperatures 

Autosampler: 4° 

Column: 30° 

Flow rate: 1.0 mL/min 

Injection volume: 15 µL 

System suitability 

Sample: Standard solution 

[Note—The retention time for chloramphenicol is about 6.3 min.] 

Suitability requirements 

Tailing factor: NMT 2.0 

Relative standard deviation: NMT 2.0% for replicate injections 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of chloramphenicol (C₁₁H₁₂Cl₂N₂O₅.) in the portion of Oral Suspension, Veterinary taken: 

Result = (r_U/r_S) × (C_S/C_U)  × 100 

r_U = peak response of chloramphenicol from the Sample solutionn 

r_S = peak response of chloramphenicol from the Standard solution

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

C_U = nominal concentration of chloramphenicol in the Sample solution (mg/mL) 

Acceptance criteria: 90.0%–120.0% 

3 SPECIFIC TESTS 

pH 〈791〉: 4.7–5.7 

4 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Package in tight, light-resistant containers. Store in a refrigerator or at controlled room temperature. Beyond-Use Date: NMT 90 days after the date on which it was compounded, when stored in a refrigerator or at controlled room temperature Labeling: Label it to indicate that it is for veterinary use only. Label it to indicate that it is to be well-shaken before use, and to state the Beyond Use Date. 

USP Reference Standards 〈11〉 

USP Chloramphenicol RS 

 (USP 1-May-2020)