Chorionic Gonadotropin for Injection
»Chorionic Gonadotropin for Injection is a sterile,dry mixture of Chorionic Gonadotropin with suitable diluents and buffers.Its potency is not less than 80.0percent and not more than 125.0percent of the potency stated on the label in USP Chorionic Gonadotropin Units.It may contain an antimicrobial agent.
Labeling—
Label it to indicate the expiration date.
Constituted solution—
At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ—
It contains not more than 0.03USP Endotoxin Unit per USP Chorionic Gonadotropin Unit.
Uniformity of dosage units á905ñ—
Open 10containers and weigh accurately 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%.
pHá791ñ—
The pHof the solution prepared for the test for Estrogenic activityis between 6.0and 8.0.
Estrogenic activity—
When constituted as directed in the labeling,it meets the requirements of the test for Estrogenic activityunder Chorionic Gonadotropin.
Other requirements—
It meets the requirements for Sterility Tests á71ñand Labelingunder Injections á1ñ.
Assay—
Proceed with Chorionic Gonadotropin for Injection as directed in the Assayunder Chorionic Gonadotropin,using an Assay preparationobtained by diluting a portion of the solution prepared for the test for Estrogenic activityquantitatively and stepwise with the specified diluent.
Auxiliary Information—
Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 918
Pharmacopeial Forum:Volume No.29(5)Page 1504
Phone Number:1-301-816-8385