Sterile Erythromycin Ethylsuccinate
» Sterile Erythromycin Ethylsuccinate is Erythromycin Ethylsuccinate suitable for parenteral use. It has a potency equivalent to not less than 765 µg of erythromycin (C37H67NO13) per mg, calculated on the anhydrous basis.
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
Sterility 71 It meets the requirements when tested as directed for Direct Inoculation of the Culture Medium under Test for Sterility of the Product to be Examined.
Heavy metals 231 Dissolve 1 g in 25 mL of water, and proceed as directed for Method I: the limit is 0.002%.
Other requirements It conforms to the Definition, responds to the Identification test, and meets the requirements for Water, Residue on ignition, Crystallinity, and Assay under Erythromycin Ethylsuccinate.
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USP32NF27 Page 2292Pharmacopeial Forum: Volume No. 34(5) Page 1158