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Nom du produit
Acide acétique glacial, United States Pharmacopeia (USP) Reference Standard
InChI
1S/C2H4O2/c1-2(3)4/h1H3,(H,3,4)
SMILES string
[F2C(F2C)13F3C]C(O)=O
InChI key
QTBSBXVTEAMEQO-UHFFFAOYSA-N
grade
pharmaceutical primary standard
vapor density
2.07 (vs air)
API family
glacial acetic acid
form
liquid
autoignition temp.
800 °F
expl. lim.
16 %, 92 °F
4 %, 59 °F
manufacturer/tradename
USP
technique(s)
gas chromatography (GC): suitable
refractive index
n20/D 1.371 (lit.)
bp
117-118 °C (lit.)
mp
16.2 °C (lit.)
density
1.04 g/mL at 25 °C (lit.)
application(s)
USP Biologics
pharmaceutical (small molecule)
format
neat
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Application
Further information is available in the general chapter, 503- ACETIC ACID IN PEPTIDES, USP43-NF38 - 6741 of the USP (United States Pharmacopeia).
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.
Other Notes
signalword
Danger
hcodes
Hazard Classifications
Eye Dam. 1 - Flam. Liq. 3 - Skin Corr. 1A
Classe de stockage
3 - Flammable liquids
wgk
WGK 1
flash_point_f
102.2 °F - closed cup
flash_point_c
39 °C - closed cup
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