Sterile Erythromycin Gluceptate
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 600 µg of erythromycin (C37H67NO13) per mg, calculated on the anhydrous basis. In addition, where packaged for dispensing, it contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of erythromycin (C37H67NO13).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
Identification, Infrared Absorption 197M.
Bacterial endotoxins 85 It contains not more than 1.0 USP Endotoxin Unit per mg of erythromycin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 6.0 and 8.0, in a solution containing 25 mg per mL.
Water, Method I 921: not more than 5.0%.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements Where packaged for dispensing it meets the requirements for Uniformity of Dosage Units 905 and Constituted Solutions and Labeling under Injections 1.
Assay Proceed as directed for erythromycin under AntibioticsMicrobial Assays 81, using an accurately weighed quantity of Sterile Erythromycin Gluceptate dissolved in methanol to yield a solution containing the equivalent of about 10 mg of erythromycin per mL. Dilute this solution quantitatively with 9 volumes of Buffer No. 3 to obtain a stock solution containing the equivalent of about 1 mg 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. 3 to obtain a stock solution having a convenient concentration. Dilute a portion of the stock solution quantitatively with Buffer No. 3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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USP32NF27 Page 2295