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960.13[23067-13-2].
197M
.
85—
It contains not more than 1.0 USP Endotoxin Unit per mg of erythromycin.
71—
It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
791:
between 6.0 and 8.0, in a solution containing 25 mg per mL.
921:
not more than 5.0%.
788:
meets the requirements for small-volume injections.
467:
meets the requirements.
905 and Constituted Solutions and Labeling under Injections 1.
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.