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. Based on comments received, the proposal in PF 51(5) has been canceled and is being replaced with a new proposal. It is being proposed to revise the monograph with the following changes:
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Update the Chemical Information section to remove "(as free base)", because 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 specification 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 specified limit for "Any unspecified impurities" for Teriparatide produced from chemical process and specify that the current specification of "largest other individual related impurities" is limited to Teriparatide produced from rDNA process in the test for Product-Related Impurities.
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Revise the Acceptance criteria in the test for Product-Related Impurities to move the relative retention times to the new Table 3 in System suitability and add Table 5 with acceptance criteria for product-related impurities in aqueous Teriparatide.
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Add the rhPTH (1–30) and teriparatide succinimide (30) impurities to 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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Delete the reference to Tests for Specified Microorganisms 〈62〉 to improve clarity, because no related acceptance criteria in this general chapter is applicable to the article.
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Add a specification 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-3356