Chlortetracycline Hydrochloride Tablets

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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(This monograph has been updated to the current USP style. No revisions or changes to tests have been made.) 

1 DEFINITION 

Chlortetracycline Hydrochloride Tablets contain NLT 90.0% and NMT 120.0% of the labeled amount of chlortetracycline hydrochloride (C₂₂H₂₃ClN₂O₈.HCl).  

2 IDENTIFICATION 

A. Identification—Tetracyclines 〈193〉, Procedures, Method II 

Sample solution: 0.5 mg/mL of chlortetracycline hydrochloride in methanol from a suitable quantity of finely ground Tablet powder; shake the solution, then filter. 

Resolution solution: 0.5 mg/mL each of USP Chlortetracycline Hydrochloride RS, USP Oxytetracycline RS, and USP Tetracycline Hydrochloride RS in methanol 

Analysis: Proceed as directed in the chapter. 

Acceptance criteria: Meet the requirements 

3 ASSAY 

Procedure 

Standard: USP Chlortetracycline Hydrochloride RS 

Sample solution: Transfer NLT 5 Tablets to a high-speed glass blender jar containing a suitable volume of 0.01 N hydrochloric acid, so that after blending for 3–5 min, a solution of convenient concentration is obtained. 

Analysis: Proceed as directed for chlortetracycline under Antibiotics—Microbial Assays 〈81〉, using a suitable volume of the Sample solution diluted with water to obtain a test dilution having a concentration assumed to be equal to the median dose level of the Standard. Acceptance criteria: 90.0%–120.0% 

4 PERFORMANCE TESTS 

Disintegration 〈701〉 

Medium: Simulated gastric uid TS in place of water 

Time: 1h 

Acceptance criteria: Meet the requirements 

Uniformity of Dosage Units 〈905〉, Weight Variation: Meet the requirements 

5 SPECIFIC TESTS 

Water Determination 〈921〉, Method I 

Sample: A quantity of finely ground Tablet powder 

Acceptance criteria: NMT 3%; or where the Tablets have a diameter of greater than 15 mm, NMT 6% 

6 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in tight containers, protected from light. 

Labeling: Label the Tablets to indicate that they are intended for veterinary use only. 

USP Reference Standards 〈11〉 

USP Chlortetracycline Hydrochloride RS 

USP Oxytetracycline RS 

USP Tetracycline Hydrochloride RS