Spectinomycin Hydrochloride
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C14H24N2O7·2HCl·5H2O 495.35

4H-Pyrano[2,3-b][1,4]benzodioxin-4-one,decahydro-4a,7,9-trihydroxy-2-methyl-6,8-bis(methylamino)-,dihydrochloride,pentahydrate,[2R-(2a,4ab,5ab,6b,7b,8b,9a,9aa,10ab)]-.
(2R,4aR,5aR,6S,7S,8R,9S,9aR,10aS)-Decahydro-4a,7,9-trihydroxy-2-methyl-6,8-bis(methylamino)-4H-pyrano[2,3-b]1,4]benzodioxin-4-one dihydrochloride pentahydrate [22189-32-8].

Anhydrous 405.28 [21736-83-4].
»Spectinomycin Hydrochloride has a potency equivalent to not less than 603µg 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.
Identification,Infrared Absorption á197Mñ— Do not dry specimen.
Crystallinity á695ñ: meets the requirements.
Bacterial endotoxins á85ñ— 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 0.09USP Endotoxin Unit per mg of spectinomycin.
Sterility á71ñ— 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.
pHá791ñ: between 3.8and 5.6,in a solution containing 10mg per mL.
Water,Method Iá921ñ: between 16.0%and 20.0%.
Residue on ignition á281ñ: not more than 1.0%,the charred residue being moistened with 2mLof nitric acid and 5drops of sulfuric acid.
Assay—
Internal standard solution— Dissolve triphenylantimony in dimethylformamide to obtain a solution containing about 2mg per mL.
Standard preparation— Transfer about 30mg of USP Spectinomycin Hydrochloride RS,accurately weighed,to a glass-stoppered,25-mLconical flask.Add 10.0mLof Internal standard solutionand 1.0mLof hexamethyldisilazane,and shake intermittently for 1hour.
Assay preparation— Proceed as directed under Standard preparationusing Spectinomycin Hydrochloride.
Chromatographic system (see Chromatography á621ñ)—The gas chromatograph is equipped with a flame-ionization detector and contains a 3-mm ×60-cm glass column packed with 5percent phase G27on 80-to 100-mesh support S1AB.The column and detector are maintained at about 190and 220,respectively,and the injection port at about 215,and dry helium is used as the carrier gas at a flow rate of about 45mLper 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 preparationis not more than 3.5%.
Procedure— Separately inject equal volumes (about 1µL)of the Standard preparationand the Assay preparationinto 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,RS,in the chromatogram from the Standard preparation.Calculate the quantity,in µg,of C14H24N2O7in the portion of Spectinomycin Hydrochloride taken to prepare the Assay preparationby the formula:
P(WS)(RU/RS),
in which Pis the potency of USP Spectinomycin Hydrochloride RS,in µg of spectinomycin per mg;and WSis the weight,in mg,of USP Spectinomycin Hydrochloride RStaken from the Standard preparation;and the other terms are as defined above.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1798
Phone Number:1-301-816-8335