1.37000

Acetic acid

100%, EMPROVE^® EXPERT, Ph. Eur., BP, ChP, JP, USP

• Synonim(y): Glacial acetic acid
• Wzór liniowy: CH₃CO₂H
• Numer CAS: 64-19-7
• Masa cząsteczkowa: 60.05
• UNSPSC Code: 12352106
• Beilstein/REAXYS Number: 506007
• MDL number: MFCD00036152

Właściwości

• Quality Segment: 500
• agency: BP, ChP, JP, Ph. Eur., USP
• vapor density: 2.07 (vs air)
• product line: EMPROVE^® EXPERT
• assay: 100%
• form: liquid
• autoignition temp.: 800 °F
• expl. lim.: 16 %, 92 °F, 4 %, 59 °F
• technique(s): API processing | salt formation: suitable
• impurities: endotoxins, low
• refractive index: n20/D 1.371 (lit.)
• pH: 2.5 (20 °C, 50 g/L in H₂O)
• bp: 117-118 °C (lit.)
• mp: 16.2 °C (lit.)
• solubility: 602.9 g/L at 25 °C (at 1.013 hPa - completely soluble in water)
• density: 1.04 g/mL at 25 °C (lit.)
• application(s): liquid formulation; parenterals; pharma/biopharma processes; pharmaceutical
• storage temp.: 15-25°C
• SMILES string: [F2C(F2C)13F3C]C(O)=O
• InChI: 1S/C2H4O2/c1-2(3)4/h1H3,(H,3,4)
• InChI key: QTBSBXVTEAMEQO-UHFFFAOYSA-N

Opis

General description

Every bio-manufacturing process involves buffer preparation, pH adjustment, and cleaning to protect equipment and prevent cross-contamination. All our GMP (IPEC/EXCiPACT) solutions for buffer preparation and CIP are manufactured under Excipient GMP conditions and feature low bioburden levels, backed by our Emprove^® Program for exceptional quality and documentation support.
As a result, you can integrate our solutions directly into your biopharmaceutical production process. In addition to our comprehensive portfolio, we also offer custom manufacturing services to meet your exact needs.

Application

Glacial acetic acid can be used:

• As a buffering agent for the chromatography and purification processes of proteins and other biological products.
• As a counter ion, enhancing the solubility and other physicochemical properties of active pharmaceutical ingredients (APIs).
• To reduce the pH during virus inactivation process.
• As a stabilizer during the final formulation of APIs.
• In cleaning in place (CIP) applications as well as for pH adjustment.

Features and Benefits

• Comprehensive, up-to-date documentation you need to navigate regulatory challenges, manage risks, and improve processes.
• Suitable for higher-risk applications where the lowest microbiological and endotoxin levels are of utmost importance.
• Emprove^® products are designed to facilitate compliance with global regulations (e.g., ICH Q7, EU GMP, USP, EP).
• Detailed supply chain and manufacturing information helps ensure traceability and continuity, which is critical for GMP manufacturing.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

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Informacja o środkach bezpieczeństwa

• pictograms: GHS02,GHS05
• signalword: Danger
• hcodes: H226,H314
• pcodes: P210 - P233 - P240 - P280 - P303 + P361 + P353 - P305 + P351 + P338
• Hazard Classifications: Eye Dam. 1 - Flam. Liq. 3 - Skin Corr. 1A
• Klasa składowania: 3 - Flammable liquids
• flash_point_f: 102.2 °F - closed cup
• flash_point_c: 39 °C - closed cup