Sterile Erythromycin Gluceptate
C37H67NO13·C7H14O8 960.13

Erythromycin monoglucoheptonate (salt).
Erythromycin glucoheptonate (1:1)(salt). [23067-13-2].
»Sterile Erythromycin Gluceptate is erythromycin gluceptate suitable for parenteral use.It has a potency equivalent to not less than 600µg of erythromycin (C37H67NO13)per mg,calculated on the anhydrous basis.In addition,where packaged for dispensing,it contains the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of erythromycin (C37H67NO13).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Identification,Infrared Absorption á197Mñ.
Bacterial endotoxins á85ñ— It contains not more than 1.0USP Endotoxin Unit per mg of erythromycin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 6.0and 8.0,in a solution containing 25mg per mL.
Water,Method Iá921ñ: not more than 5.0%.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— Where packaged for dispensing it meets the requirements for Uniformity of Dosage Units á905ñand Constituted Solutionsand Labelingunder Injections á1ñ.
Assay— Proceed as directed for erythromycin under Antibiotics—Microbial Assays á81ñ,using an accurately weighed quantity of Sterile Erythromycin Gluceptate dissolved in methanol to yield a solution containing the equivalent of about 10mg of erythromycin per mL.Dilute this solution quantitatively with 9volumes of Buffer No.3to obtain a stock solution containing the equivalent of about 1mg of erythromycin per mL.Where it is packaged for dispensing,constitute Sterile Erythromycin Gluceptate as directed in the labeling.Withdraw all of the withdrawable contents where the package is represented as being a single-dose container;or where the labeling specifies the amount of potency in a given volume of the resultant preparation,withdraw an accurately measured volume.Dilute quantitatively with Buffer No.3to obtain a stock solution having a convenient concentration.Dilute a portion of the stock solution quantitatively with Buffer No.3to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 769
Phone Number:1-301-816-8335