BRIEFING
Teriparatide Injection. This proposal is based on the version of the monograph official as of December 12, 2023. It is being proposed to revise the monograph with the following changes:
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Add the HPLC-DAD based UV Spectral Analysis test to Specific Tests.
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Move the Bioidentity test from Identification to Specific Tests.
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Correct the amino acid name from Asn 30 to Asp 30 in the Product-Related Impurities test.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
Stakeholders are encouraged to provide feedback on whether the Bioidentity test should be retained or removed from the monograph.
(BIO1: K. Chandra)
Case ID: SUB-2548