Spectinomycin for Injectable Suspension

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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Spectinomycin for Injectable Suspension contains an amount of Spectinomycin Hydrochloride equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of spectinomycin (C₁₄H₂₄N₂O₇).

Packaging and storage—Preserve as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for constitution. USP REFERENCE STANDARDS 〈11〉—

USP Spectinomycin Hydrochloride RS

Change to read:

Identification—Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy : 197M (CN 1-May-2020) . Do not dry specimen.

PH 〈791〉: between 4.0 and 7.0, in the suspension constituted as directed in the labeling.

Other requirements—It conforms to the Definition, and meets the requirements for Crystallinity, Bacterial endotoxins, Sterility, Water, and Residue on ignition under Spectinomycin Hydrochloride. It meets also the requirements for Uniformity of Dosage Units 〈905〉 and Labeling 〈7〉, Labels and Labeling for Injectable Products.

Assay—

Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Spectinomycin Hydrochloride.

Assay preparation 1—Suspend the contents of 1 container of Spectinomycin for Injectable Suspension in water, and dilute quantitatively with water to obtain a stock solution containing about 20 mg of spectinomycin per mL. Transfer 1.0 mL of this solution to a glass-stoppered, 25- mL conical flask, and freeze-dry. Add 10.0 mL of Internal standard solution and 1.0 mL of hexamethyldisilazane, and shake intermittently for 1 hour.

Assay preparation 2 (where the label states the quantity of spectinomycin in a given volume of constituted suspension)—Constitute 1 container of Spectinomycin for Injectable Suspension in a volume of water, accurately measured, corresponding to the volume of diluent specified in the labeling. Dilute an accurately measured portion of the constituted suspension quantitatively with water to obtain a stock solution containing about 20 mg of spectinomycin per mL. Transfer 1.0 mL of this solution to a glass-stoppered, 25-mL conical flask, and freeze-dry. Add 10.0 mL of Internal standard solution and 1.0 mL of hexamethyldisilazane, and shake intermittently for 1 hour.

Procedure—Proceed as directed in the Assay under Spectinomycin Hydrochloride. Calculate the quantity, in g, of C H N O in the container of Spectinomycin for Injectable Suspension taken to prepare Assay preparation 1 taken by the formula:

(L₁/D₁)(P/1000)(W_S)(R_U/R_S)

in which L is the labeled quantity, in g, of C₁₄H₂₄N₂O₇ in the container, and D is the concentration, in mg per mL, of spectinomycin in the stock

solution used to prepare Assay preparation 1, on the basis of the labeled quantity in the container and the extent of dilution, and the other terms are as defined therein. Calculate the quantity, in mg, of C H N O in each mL of constituted Injectable Suspension taken to prepare

Assay preparation 2 taken by the formula:

(L₂/D₂)(P/1000)(W_S)(R_U/R_S)

in which L is the labeled quantity, in mg, of C₁₄H₂₄N₂O₇ in each mL of constituted suspension of Spectinomycin for Injectable Suspension, and D is the concentration, in mg per mL, of spectinomycin in the stock solution used to prepare Assay preparation 2, on the basis of the labeled quantity in each mL of constituted suspension and the extent of dilution.