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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:

  1. 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.

  2. 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

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