|
|
1092.22
-D-galactopyranosyl-D-gluconate) (salt).
[3847-29-8].
11
—
USP Endotoxin RS. USP Erythromycin RS. USP Erythromycin Lactobionate RS.
1.
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.
85—
It contains not more than 1.0 USP Endotoxin Unit per mg of erythromycin.
791:
between 6.5 and 7.5, in a solution containing the equivalent of 50 mg of erythromycin per mL.
921:
not more than 5.0%.
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.
231:
0.005%.
467:
meets the requirements.
1.
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.