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General description
Glacial acetic acid is a commonly used solvent and pH modifier in peptide synthesis and purification. It may be present as a residual process reagent. The USP standard is used to quantify acetic acid levels in peptide APIs and assess formulation stability.
The USP biologics peptides category encompasses a diverse range of therapeutic peptides that are essential in managing various medical conditions. These peptides, typically consisting of amino acid sequences of 40 residues or less, are critical for the development of high-quality medicines. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of peptide therapeutics throughout their lifecycle.
The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.
Application
Glacial acetic acid USP reference standard for use in specified quality tests and assays. It is also used to prepare standard solution by using liquid chromatography coupled to a UV detector according to the general chapter of United States Pharmacopeia (USP).[1] Based directly on official monographs published in the USP-NF, these highly characterized physical specimens are used in testing by pharmaceutical and related industries to help ensure the identity, strength, quality, and purity of peptide-based medicines.
Further information is available in the general chapter, 503- ACETIC ACID IN PEPTIDES, USP43-NF38 – 6741 of the USP (United States Pharmacopeia).
Other Notes
Sales restrictions may apply.
This product is part of the USP Biologics program.
