Erythromycin Intramammary Infusion
» Erythromycin Intramammary Infusion is a solution of Erythromycin in a suitable vegetable oil vehicle. It contains one or more suitable preservatives. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C37H67NO13.
Packaging and storage Preserve in single-dose disposable syringes that are well-closed containers.
Labeling Label it to indicate that it is for veterinary use only.
Identification Transfer a quantity of Intramammary Infusion, equivalent to about 5 mg of erythromycin, to a separator containing 50 mL of solvent hexane. Shake until dissolved. Extract with three separate 20-mL portions of methanol. Combine the methanol extracts in a beaker, and evaporate to dryness. Dissolve the residue in 2 mL of methanol (test solution). Proceed as directed in the Identification test under Erythromycin Delayed-Release Capsules, beginning with Prepare a Standard solution of USP Erythromycin RS.
Minimum fill 755: meets the requirements.
Water, Method I 921: not more than 1.0%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
Assay Transfer the contents of a syringe of Intramammary Infusion to a separator containing 50 mL of solvent hexane. Shake until dissolved. Wash with four separate 20-mL portions of a mixture of methanol and water (4:1). Combine the washings in a 100-mL volumetric flask, dilute with the methanol and water solution to volume, and mix. Proceed as directed for erythromycin under AntibioticsMicrobial Assays 81, using an accurately measured volume of this stock solution diluted quantitatively with Buffer No. 3 to yield a Test Dilution having a concentration of erythromycin assumed to be equal to the median dose level of the Reference Standard.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 2285