Chlortetracycline and Sulfamethazine Bisulfates Soluble Powder
» Chlortetracycline and Sulfamethazine Bisulfates Soluble Powder is a dry mixture of Chlortetracycline Bisulfate and Sulfamethazine Bisulfate and one or more suitable buffers and diluents. It contains the equivalent of not less than 85.0 percent and not more than 125.0 percent of the labeled amounts of chlortetracycline hydrochloride (C22H24N2O8·HCl) and sulfamethazine (C12H14N4O2S).
Packaging and storage Preserve in tight, light-resistant containers.
Labeling Label it to indicate that it is intended for veterinary use only.
USP Reference standards 11
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 for chlortetracycline hydrochloride Proceed as directed for chlortetracycline under AntibioticsMicrobial Assays 81, using an accurately weighed quantity of Powder, equivalent to about 100 mg of chlortetracycline hydrochloride, dissolved in an accurately measured volume of 0.01 N hydrochloric acid to obtain a stock solution having a convenient concentration. Dilute an accurately measured volume of this stock solution quantitatively and stepwise with water to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Assay for sulfamethazine Proceed as directed under Nitrite Titration 451, using an accurately weighed quantity of Powder, equivalent to about 500 mg of sulfamethazine. Each mL of 0.1 M sodium nitrite is equivalent to 27.83 mg of sulfamethazine (C12H14N4O2S).
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USP35NF30 Page 2647