Sterile Erythromycin Lactobionate
»Sterile Erythromycin Lactobionate has a potency equivalent to not less than 525µg 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 120.0percent of the labeled amount of erythromycin (C37H67NO13).
USP Reference standards á11ñ—
USP Endotoxin RS.USP Erythromycin RS.USP Erythromycin Lactobionate RS.
Identification,Infrared Absorption á197Mñ:
the specimen and the Reference Standard being previously dried in vacuum at a pressure not exceeding 5mm of mercury at 60
for 3hours.
for 3hours.
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 6.5and 7.5,in a solution containing the equivalent of 50mg of erythromycin per mL.
Water,Method Iá921ñ:
not more than 5.0%.
Particulate matter á788ñ:
meets the requirements for small-volume injections when it is diluted with filtered water to a concentration of not more than 5mg of erythromycin per mLbefore the test is performed.
Residue on ignition á281ñ:
not more than 2.0%,the charred residue being moistened with 2mLof nitric acid and 5drops of sulfuric acid.
Heavy metals,Method IIá231ñ:
0.005%.
Other requirements—
Where packaged for dispensing,it meets the requirements for Uniformity of Dosage Units á905ñand for Constituted Solutionsand Labelingunder Injections á1ñ.
Assay—
Standard preparation—
Prepare as directed for erythromycin under Antibiotics—Microbial Assays á81ñ.
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 10mg of erythromycin per mL.Dilute this stock solution quantitatively with Buffer No.3(see Media and Diluentsunder Antibiotics—Microbial Assays á81ñ)to obtain a Test Dilutionhaving 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.3to obtain a Test Dilutionhaving 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 1container 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.3to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Procedure—
Proceed as directed for erythromycin under Antibiotics—Microbial Assays á81ñ.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 770
Phone Number:1-301-816-8335