Chlortetracycline Hydrochloride Ophthalmic Ointment

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 

Chlortetracycline Hydrochloride Ophthalmic Ointment contains NLT 90.0% and NMT 125.0% of the labeled amount of chlortetracycline hydrochloride (C₂₂H₂₃ClN₂O₈.HCl). 

2 ASSAY 

Procedure 

(See Antibiotics—Microbial Assays 〈81〉.) 

Sample solution: Shake a portion of Ophthalmic Ointment containing nominally 10 mg of chlortetracycline hydrochloride in a separator with 50 mL of ether, and extract with four 20-mL portions of 0.01 N hydrochloric acid. Combine the aqueous extracts in a 100-mL volumetric flask, and dilute with 0.01 N hydrochloric acid to volume. 

Analysis: Proceed as directed in the chapter. Dilute the Sample solution with water to obtain a Test Dilution having a chlortetracycline hydrochloride concentration that is nominally equivalent to the median level of the standard. 

Acceptance criteria: 90.0%–125.0% 

3 SPECIFIC TESTS 

Sterility Tests 〈71〉: Meets the requirements 

Other Requirements: It meets the requirements for Particulate and Foreign Matter and Container Contents in Ophthalmic Products—Quality Tests 〈771〉, Drug Product Quality, Universal Tests, Particulate and Foreign Matter and Container Contents. 

4 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in collapsible ophthalmic ointment tubes. 

USP Reference Standards 〈11〉 

USP Chlortetracycline Hydrochloride RS