Menotropins for Injection
» Menotropins for Injection is a sterile, freeze-dried mixture of menotropins and suitable excipients. Its potency is not less than 80 percent and not more than 125 percent of each of the Follicle-stimulating Hormone and Luteinizing Hormone potencies stated on the label. It may contain an antimicrobial agent.
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
USP Endotoxin RS.
USP Human Chorionic Gonadotropin RS.
USP Menotropins RS.
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85 It contains not more than 2.5 USP Endotoxin Units per USP Follicle-stimulating Hormone Unit.
pH 791: between 6.0 and 7.0, in the solution constituted as directed in the labeling.
Uniformity of dosage units 905 Open 10 containers and accurately weigh each individual container and its contents, taking care to preserve the identity of each container. Remove the contents of each container by rinsing thoroughly with water, dry at 105 to constant weight, and reweigh. Calculate for each container the net weight of its contents by subtracting the weight of the dry, empty container from its initial gross weight. Determine the average weight of the contents and the relative standard deviation (see Calculation of the Relative Standard Deviation under Uniformity of Dosage Units 905). The requirements are met if the weight of the contents of each container does not deviate from the average weight by more than 5.0% and the relative standard deviation of the 10 containers is not greater than 3.0%. If the requirements of the test are not met, test 20 additional containers. The requirements are met if the net weight of not more than 1 container of the 30 deviates by more than 7.5% from the average weight of the contents of the 30 containers and the relative standard deviation of the 30 containers is not greater than 3.3%.
Other requirements It meets the requirements for Sterility Tests 71 and Labeling under Injections 1.
Assay Using an Assay preparation obtained by diluting a portion of the solution constituted as directed in the labeling, proceed with Menotropins for Injection as directed in the Assay for luteinizing hormone and the Assay for follicle-stimulating hormone under Menotropins.
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USP32NF27 Page 2880Pharmacopeial Forum: Volume No. 29(5) Page 1532