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Sterile Erythromycin Lactobionate
» Sterile Erythromycin Lactobionate has a potency equivalent to not less than 525 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 120.0 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: 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.
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 6.5 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 it is diluted with filtered water to a concentration of not more than 5 mg of erythromycin per mL before the test is performed.
Residue on ignition 281: not more than 2.0%, the charred residue being moistened with 2 mL of nitric acid and 5 drops of sulfuric acid.
Heavy metals, Method II 231: 0.005%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— Where packaged for dispensing, it meets the requirements for Uniformity of Dosage Units 905 and for Constituted Solutions and Labeling under Injections 1.
Assay—
Standard preparation— Prepare as directed for erythromycin under Antibiotics—Microbial Assays 81.
Assay preparation 1— Dissolve an accurately weighed quantity of Sterile Erythromycin Lactobionate quantitatively in methanol 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 (see Media and Diluents under Antibiotics—Microbial Assays 81) to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Assay preparation 2 (where it is packaged for dispensing and is represented as being in a single-dose container)—Constitute Sterile Erythromycin Lactobionate in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labeling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and dilute 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.
Assay preparation 3 (where the label states the quantity of erythromycin in a given volume of constituted solution)—Constitute 1 container of Sterile Erythromycin Lactobionate in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labeling. Dilute an accurately measured volume of the constituted 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.
Procedure— Proceed as directed for erythromycin under Antibiotics—Microbial Assays 81.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 842
Phone Number : 1-301-816-8223