Erythromycin Lactobionate for Injection
Erythromycin mono(4-O--d-galactopyranosyl-d-gluconate) (salt).
Erythromycin lactobionate (1:1) (salt) [3847-29-8].
» Erythromycin Lactobionate for Injection is a sterile, dry mixture of erythromycin lactobionate and a suitable preservative. It contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of erythromycin (C37H67NO13).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
USP Endotoxin RS.
USP Erythromycin RS.
USP Erythromycin Lactobionate RS.
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification, Infrared Absorption 197M: the specimen and the Reference Standard being previously dried in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours.
Bacterial endotoxins 85 It contains not more than 1.0 USP Endotoxin Unit per mg of erythromycin.
pH 791: between 6.5 and 7.5, in a solution containing the equivalent of 50 mg of erythromycin per mL.
Water, Method I 921: not more than 5.0%.
Particulate matter 788: meets the requirements for small-volume injections when the constituted solution is diluted with filtered water to a concentration of not more than 5 mg of erythromycin base per mL before the test is performed.
Heavy metals, Method II 231: 0.005%.
Other requirements It meets the requirements under Injections 1.
Assay Proceed as directed for erythromycin under AntibioticsMicrobial Assays 81, using Erythromycin Lactobionate for Injection constituted 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 erythromycin equivalent in a given volume of the resultant preparation, withdraw an accurately measured volume. Dilute quantitatively with water to obtain a stock solution containing the equivalent of about 10 mg of erythromycin per mL. Dilute this 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