Chlortetracycline Hydrochloride Soluble Powder

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 Soluble Powder contains NLT 90.0% and NMT 125.0% of the labeled amount of chlortetracycline hydrochloride (C₂₂H₂₃ClN₂O₈.HCl). 

2 ASSAY 

Procedure 

Standard: USP Chlortetracycline Hydrochloride RS 

Sample solution 1 (where it is labeled on a weight basis): Dissolve about 3 g of Powder in an accurately measured volume of 0.01 N hydrochloric acid sufficient to obtain a solution containing NLT 1000 µg/mL of chlortetracycline hydrochloride (C₂₂H₂₃ClN₂O₈.HCl). 

Sample solution 2 (where the label states the amount of chlortetracycline in the immediate container): Transfer the contents of 1 container of Powder to an accurately measured volume of 0.01 N hydrochloric acid sufficient to obtain a solution containing NLT 1000 µg/mL of chlortetracycline hydrochloride (C₂₂H₂₃ClN₂O₈.HCl). 

Analysis: Proceed with Powder as directed for chlortetracycline in Antibiotics—Microbial Assays 〈81〉, using an accurately measured volume of the Sample solution diluted quantitatively and stepwise with water to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard. 

Acceptance criteria: 90.0%–125.0% 

3 SPECIFIC TESTS 

Loss on Drying 〈731〉 

Sample: About 100 mg, accurately weighed 

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

4 ADDITIONAL REQUIREMENTS 

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

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

USP Reference Standards 〈11〉 

USP Chlortetracycline Hydrochloride RS