1005706
USP
Glacial acetic acid
United States Pharmacopeia (USP) Reference Standard
Synonym(s):
Acetic acid, Ethanoic acid, Methanecarboxylic acid, Glacial acetic acid
About This Item
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
SMILES string
[F2C(F2C)13F3C]C(O)=O
InChI
1S/C2H4O2/c1-2(3)4/h1H3,(H,3,4)
InChI key
QTBSBXVTEAMEQO-UHFFFAOYSA-N
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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
Further information is available in the general chapter, 503- ACETIC ACID IN PEPTIDES, USP43-NF38 - 6741 of the USP (United States Pharmacopeia).
Other Notes
Signal Word
Danger
Hazard Statements
Precautionary Statements
Hazard Classifications
Eye Dam. 1 - Flam. Liq. 3 - Skin Corr. 1A
Storage Class Code
3 - Flammable liquids
WGK
WGK 1
Flash Point(F)
102.2 °F - closed cup
Flash Point(C)
39 °C - closed cup
Regulatory Information
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