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.
Identification,
Infrared Absorption 197S
Solution:
1 in 100.
Medium:
chloroform.
Cell size:
1.0 mm.
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 and meets the requirements for Water, Residue on ignition, Crystallinity, and the Assay under Erythromycin Ethylsuccinate.
Auxiliary Information
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USP35NF30 Page 3088
Pharmacopeial Forum: Volume No. 34(5) Page 1158
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