Spectinomycin Hydrochloride
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Spectinomycin Hydrochloride has a potency equivalent to not less than 603 µg of spectinomycin (C14H24N2O7) per mg.
Packaging and storage—Preserve in tight containers.
Labeling—Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
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.
CRYSTALLINITY 〈695〉: meets the requirements.
BACTERIAL ENDOTOXINS TEST 〈85〉 —Where the label states that Spectinomycin Hydrochloride is sterile or that it must be subjected to further processing during the preparation of injectable dosage forms, it contains not more than 0.09 USP Endotoxin Unit per mg of spectinomycin.
STERILITY TESTS 〈71〉 —Where the label states that Spectinomycin Hydrochloride is sterile, it meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
PH 〈791〉: between 3.8 and 5.6, in a solution containing 10 mg per mL.
WATER DETERMINATION, Method I 〈921〉: between 16.0% and 20.0%.
RESIDUE ON IGNITION 〈281〉: not more than 1.0%, the charred residue being moistened with 2 mL of nitric acid and 5 drops of sulfuric acid.
Assay—
Internal standard solution—Dissolve triphenylantimony in dimethylformamide to obtain a solution containing about 2 mg per mL. Standard preparation—Transfer about 30 mg of USP Spectinomycin Hydrochloride RS, accurately weighed, to a glass-stoppered, 25-mL conical flask. Add 10.0 mL of Internal standard solution and 1.0 mL of hexamethyldisilazane, and shake intermittently for 1 hour.
Assay preparation—Proceed as directed under Standard preparation using Spectinomycin Hydrochloride.
Chromatographic system (see Chromatography 〈621〉)—The gas chromatograph is equipped with a flame-ionization detector and contains a 3- mm × 60-cm glass column packed with 5 percent phase G27 on 80- to 100-mesh support S1AB. The column and detector are maintained at about 190° and 220°, respectively, and the injection port at about 215°, and dry helium is used as the carrier gas at a flow rate of about 45 mL per minute. Chromatograph the Standard preparation, and record the chromatogram as directed for Procedure: the resolution, R, between the major peaks is not less than 2.0; and the relative standard deviation of the peak response ratios, RS, from replicate injections of the Standard preparation is not more than 3.5%.
Procedure—Separately inject equal volumes (about 1 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the ratio, RU, of the response of the spectinomycin peak to the response of the internal standard peak in the chromatogram from the Assay preparation, and similarly calculate the ratio, R , in the chromatogram from the Standard preparation. Calculate the quantity, in µg, of C14H24N2O7 in the portion of Spectinomycin Hydrochloride taken to prepare the Assay preparation by the formula:
P(WS)(RU/RS)
in which P is the potency of USP Spectinomycin Hydrochloride RS, in µg of spectinomycin per mg; and W is the weight, in mg, of USP Spectinomycin Hydrochloride RS taken from the Standard preparation; and the other terms are as defined above.
