l-Phenylalanine, l-seryl-l-valyl-l-seryl-l-α-glutamyl-l-isoleucyl-l-glutaminyl-l-leucyl-l-methionyl-l-histidyl-l-asparaginyl-l-leucylglycyl-l-lysyl-l-histidyl-l-leucyl-l-asparaginyl-l-seryl-l-methionyl-l-α-glutamyl-l-arginyl-l-valyl-l-α-glutamyl-l-triptophyl-l-leucyl-l-arginyl-l-lysyl-l-lysyl-l-leucyl-l-glutaminyl-l-α-aspartyl-l-valyl-l-histidyl-l-asparaginyl-;
l-Seryl-l-valyl-l-seryl-l-α-glutamyl-l-isoleucyl-l-glutaminyl-l-leucyl-l-methionyl-l-histidyl-l-asparaginyl-l-leucylglycyl-l-lysyl-l-histidyl-l-leucyl-l-asparaginyl-l-seryl-l-methionyl-l-α-glutamyl-l-arginyl-l-valyl-l-α-glutamyl-l-tryptophyl-l-leucyl-l-arginyl-l-lysyl-l-lysyl-l-leucyl-l-glutaminyl-l-α-aspartyl-l-valyl-l-histidyl-l-asparaginyl-l-phenylalanine. [52232-67-4]
BRIEFING
Teriparatide. This proposal is based on the version of the monograph official as of April 1, 2024. It is proposed to revise the monograph with the following changes:
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The Chemical Information section has been updated by removing "(as free base)" as the molecular weight, molecular formula, and CAS number provided are for free base only.
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Add a specification limit for aqueous Teriparatide in the Definition.
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Add a separate Acceptance criteria for aqueous Teriparatide in the Assay.
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Add a Note in the test for Acetate Content that it is not applicable for aqueous Teriparatide.
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Update the solutions used for System suitability and also update the dimension details of the Guard column in the test for Chloride Content.
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Add a separate table with acceptance criteria for product-related impurities in aqueous Teriparatide in the test for Product-Related Impurities.
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Add a separate criteria for aqueous Teriparatide in Microbial Enumeration Tests 〈61〉.
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The reference to Tests for Specified Microorganisms 〈62〉 is proposed for deletion to improve clarity, as no related acceptance criteria in this general chapter is applicable to the article.
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Add a Note in the test for Water Determination 〈921〉 that it is not applicable for aqueous Teriparatide.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(BIO1: K. Chandra)
Case ID—SUB-1671