Chlortetracycline Hydrochloride

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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C₂₂H₂₃ClN₂O₈.HCl    515.34 

2-Naphthacenecarboxamide, 7-chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, 

monohydrochloride [4S-(4α,4aα,5aα,6β,12aα)]-; 

(4S,4aS,5aS,6S,12aS)-7-Chloro-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2- carboxamide monohydrochloride CAS RN®: 64-72-2; UNII: O1GX33ON8R. 

1 DEFINITION 

Chlortetracycline Hydrochloride has a potency of NLT 900 µg/mg of chlortetracycline hydrochloride (C₂₂H₂₃ClN₂O₈.HCl).  

[Note—Chlortetracycline Hydrochloride labeled solely for use in preparing oral veterinary dosage forms has a potency of NLT 820 µg/mg of chlortetracycline hydrochloride (C₂₂H₂₃ClN₂O₈.HCl).] 

2 IDENTIFICATION 

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

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

Test solution: 0.5 mg/mL in methanol 

Acceptance criteria: Meets the requirements 

B. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride 

Sample solution: 1 in 20 solution 

Acceptance criteria: Meets the requirements 

3 ASSAY 

Procedure 

Standard: USP Chlortetracycline Hydrochloride RS 

Analysis: Proceed as directed under Antibiotics—Microbial Assays 〈81〉. 

Acceptance criteria: NLT 900 µg/mg of chlortetracycline hydrochloride (C₂₂H₂₃ClN₂O₈.HCl); when labeled solely for use in preparing oral veterinary dosage forms: NLT 820 µg/mg 

4 SPECIFIC TESTS 

Optical Rotation 〈781S〉, Procedures, Specific Rotation 

Sample solution: 5 mg/mL in water that has been allowed to stand in the dark for 30 min 

Acceptance criteria: −235° to −250° 

Crystallinity 〈695〉: Meets the requirements 

pH 〈791〉 

Sample solution: 10 mg/mL solution 

Acceptance criteria: 2.3–3.3 

Loss on Drying 〈731〉 

Sample: About 100 mg, accurately weighted 

Analysis: Dry Sample in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60° for 3 h. Acceptance criteria: NMT 2.0% 

Sterility Tests 〈71〉 

Sample: 3.0% in Fluid D with membrane filtration 

Acceptance criteria: Where the label states that Chlortetracycline Hydrochloride is sterile, it meets the requirements when tested as directed for Test for Sterility of the Product to Be Examined. 

5 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in tight, light-resistant containers. 

Labeling: Where it is intended for use in preparing sterile dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of sterile dosage forms. 

USP Reference Standards 〈11〉 

USP Chlortetracycline Hydrochloride RS 

USP Oxytetracycline RS 

USP Tetracycline Hydrochloride RS