Tetracycline 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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Tetracycline Hydrochloride Soluble Powder contains not less than 90.0 percent and not more than 125.0 percent of the labeled amount of C₂₂H₂₄N₂O₈ · HCl.

Packaging and storage—Preserve in tight containers.

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

USP REFERENCE STANDARDS 〈11〉—

USP Tetracycline Hydrochloride RS

Identification—Shake a suitable quantity of Powder with methanol to obtain a solution containing the equivalent of 1 mg of tetracycline hydrochloride per mL, and filter. Using the filtrate so obtained as the Test Solution, proceed as directed under Identification—Tetracyclines 〈193〉. LOSS ON DRYING 〈731〉—Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60° for 3 hours: it loses not more than 2.0% of its weight.

Assay—Transfer an accurately weighed quantity of Powder to a high-speed blender jar containing an accurately measured volume of 0.1 N hydrochloric acid, so that the solution so obtained contains not less than 150 µg of tetracycline hydrochloride per mL, and blend for about 3 to 5 minutes. Proceed as directed for tetracycline under Antibiotics—Microbial Assays 〈81〉, diluting an accurately measured volume of this solution 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.