Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.

Labeling— Label it to indicate the expiration date.

USP Reference standards 11— USP Endotoxin RS. USP Human Chorionic Gonadotropin 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 0.03 USP Endotoxin Unit per USP Chorionic Gonadotropin Unit.

Uniformity of dosage units 905— Open 10 containers 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 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%.

pH 791— The pH of the solution prepared for the test for Estrogenic activity is between 6.0 and 8.0.

Estrogenic activity— When constituted as directed in the labeling, it meets the requirements of the test for Estrogenic activity under Chorionic Gonadotropin.

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements for Sterility Tests 71 and Labeling under Injections 1.

Assay— Proceed with Chorionic Gonadotropin for Injection as directed in the Assay under Chorionic Gonadotropin, using an Assay preparation obtained by diluting a portion of the solution prepared for the test for Estrogenic activity quantitatively and stepwise with the specified diluent.

Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides

USP29–NF24 Page 1019

Phone Number : 1-301-816-8385