Chlortetracycline Hydrochloride Soluble Powder
»Chlortetracycline Hydrochloride Soluble Powder contains not less than 90.0percent and not more than 125.0percent of the labeled amount of C22H23ClN2O8·HCl.
Packaging and storage— Preserve in tight containers,protected from light.
Labeling— Label it to indicate that it is intended for oral veterinary use only.
Loss on drying á731ñ— Dry about 100mg,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 2.0%of its weight.
Assay—
Assay preparation 1 (where it is labeled on a weight basis)—Dissolve about 3g of Powder in an accurately measured volume of 0.01Nhydrochloric acid sufficient to obtain a solution containing not less than 1000µg of chlortetracycline hydrochloride (C22H23ClN2O8·HCl)per mL.
Assay preparation 2 (where the label states the amount of chlortetracycline in the immediate container)—Transfer the contents of 1container of Powder to an accurately measured volume of 0.01Nhydrochloric acid sufficient to obtain a solution containing not less than 1000µg of chlortetracycline hydrochloride (C22H23ClN2O8·HCl)per mL.
Procedure— Proceed with Powder as directed for chlortetracycline under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Assay preparationdiluted quantitatively and stepwise with water to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 460
Phone Number:1-301-816-8178