Menotropins for Injection
»Menotropins for Injection is a sterile,freeze-dried mixture of menotropins and suitable excipients.Its potency is not less than 80percent and not more than 125percent of each of the Follicle-stimulating Hormone and Luteinizing Hormone potencies stated on the label.It may contain an antimicrobial agent.
USP Reference standards á11ñ—
USP Endotoxin RS.USP Human Chorionic Gonadotropin RS.USP Menotropins RS.
Constituted solution—
At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ—
It contains not more than 2.5USP Endotoxin Units per USP Follicle-stimulating Hormone Unit.
pHá791ñ:
between 6.0and 7.0,in the solution constituted as directed in the labeling.
Uniformity of dosage units á905ñ—
Open 10containers 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 Deviationunder Uniformity of Dosage Units á905ñ).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 10containers is not greater than 3.0%.If the requirements of the test are not met,test 20additional containers.The requirements are met if the net weight of not more than 1container of the 30deviates by more than 7.5%from the average weight of the contents of the 30containers and the relative standard deviation of the 30containers is not greater than 3.3%.
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 Deviationunder Uniformity of Dosage Units á905ñ).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 10containers is not greater than 3.0%.If the requirements of the test are not met,test 20additional containers.The requirements are met if the net weight of not more than 1container of the 30deviates by more than 7.5%from the average weight of the contents of the 30containers and the relative standard deviation of the 30containers is not greater than 3.3%.
Other requirements—
It meets the requirements for Sterility Tests á71ñand Labelingunder Injections á1ñ.
Assay—
Using an Assay preparationobtained 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 hormoneand the Assay for follicle-stimulating hormoneunder Menotropins.
Auxiliary Information—
Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 1206
Pharmacopeial Forum:Volume No.29(5)Page 1532
Phone Number:1-301-816-8385