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1.00056

SAFC

Acetic acid

(glacial) 100%, EMPROVE® EXPERT, Ph. Eur., BP, ChP, JP, USP, E 260

Pharma Manufacturing

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Synonym(s):
Acetic acid, Ethanoic acid, Glacial acetic acid
Linear Formula:
CH3CO2H
CAS Number:
Molecular Weight:
60.05
Beilstein/REAXYS Number:
506007
MDL number:
UNSPSC Code:
12352106
E Number:
E260
EC Index Number:
200-580-7

agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

vapor density

2.07 (vs air)

vapor pressure

15.4 hPa ( 20 °C)

product line

EMPROVE® EXPERT

assay

≥99.8-100.5% (alkalimetric)

form

liquid

autoignition temp.

485 °C
800 °F

expl. lim.

16 %, 92 °F
4 %, 59 °F

concentration

100%

technique(s)

API processing | polymorph screening: suitable

refractive index

n20/D 1.371 (lit.)

pH

2.5 (20 °C, 50 g/L in H2O)

kinematic viscosity

1.17 cSt(20 °C)

bp

117-118 °C (lit.)

mp

16.2 °C (lit.)

transition temp

flash point 39 °C

solubility

soluble 602.9 g/L

density

1.049 g/mL at 25 °C (lit.)

anion traces

chloride (Cl-): ≤0.0002%
sulfate (SO42-): ≤0.0005%

cation traces

Al: ≤0.00005%
As: ≤0.00010%
Cu: ≤0.0005%
Fe: ≤0.0005%
Hg: ≤0.00010%
Pb: ≤0.00005%
Zn: ≤0.0005%
heavy metals (as Pb): ≤0.0005%

application(s)

liquid formulation
pharmaceutical
semi-solid formulation

storage temp.

15-25°C

SMILES string

CC(O)=O

InChI

1S/C2H4O2/c1-2(3)4/h1H3,(H,3,4)

InChI key

QTBSBXVTEAMEQO-UHFFFAOYSA-N

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General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Acetic acid can be used as acidifying agent and buffer component in a variety of pharmaceutical formulations and production processes, including e.g. plasma fractionation.

Legal Information

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

Pictograms

FlameCorrosion

signalword

Danger

hcodes

Hazard Classifications

Eye Dam. 1 - Flam. Liq. 3 - Skin Corr. 1A

wgk_germany

WGK 1


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