Goserelin Implants
BRIEFING
Goserelin Implants. This proposal is based on the version of the monograph official as of August 1, 2017. The following changes are being proposed:
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Revise the calculations for 3.6-mg Implants and 10.8-mg Implants in the test for Dissolution to align with the regulatory approved products.
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Delete USP Endotoxin RS from the USP Reference Standards section.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(BIO1: Y. Han)
Case ID—SUB-2672
USP REFERENCE STANDARDS FOR PURCHASE
USP Endotoxin RSUSP Glacial Acetic Acid RS
USP Goserelin Acetate RS
USP Goserelin Related Compound A RS
