I try to prepare spectinomycin sulfate 5120 ug/ml in a stock solution for 5 ml, but I'm stuck with the problem that I don't know how to calculate the potency if the antibiotic contains salt as in this case "sulfate". The formula provided by CLSI to calculate the potency is shown as: Potency = (Assay purity) * (Active fraction) * (1-Water Content).

Now the manufacturer gives me the certified purity: 84.6% (Mass Balance/as is basis, as spectinomycin sulfate), so everything can be filled in the formula except for active fraction because if antibiotic is free base or acid they can be represented by 1 (100%), but for the spectinomycin sulfate it contains sulfate as a salt.

I don't know what active fraction in this case should be. Please suggest me how to calculate it. The MW of spectinomycinsulfate is 502.5.

Thanks for your help.

Jay

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