Sterile Erythromycin Ethylsuccinate
»Sterile Erythromycin Ethylsuccinate is Erythromycin Ethylsuccinate suitable for parenteral use.It has a potency equivalent to not less than 765µg of erythromycin (C37H67NO13)per mg,calculated on the anhydrous basis.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Sterility á71ñ— It meets the requirements when tested as directed for Direct Inoculation of the Culture Mediumunder Test for Sterility of the Product to be Examined.
Heavy metals á231ñ— Dissolve 1g in 25mLof water,and proceed as directed for Method I:the limit is 0.002%.
Other requirements— It conforms to the Definition,responds to the Identificationtest,and meets the requirements for pH,Water,Residue on ignition,Crystallinity,and Assayunder Erythromycin Ethylsuccinate.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 766
Phone Number:1-301-816-8335