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Merck

1.37000

Acetic acid

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

Synonym(s):

Glacial acetic acid

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About This Item

Linear Formula:
CH3CO2H
CAS Number:
Molecular Weight:
60.05
UNSPSC Code:
12352106
Beilstein/REAXYS Number:
506007
MDL number:
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Quality Level

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

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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pictograms

FlameCorrosion

signalword

Danger

hcodes

Hazard Classifications

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

Storage Class

3 - Flammable liquids

flash_point_f

102.2 °F - closed cup

flash_point_c

39 °C - closed cup



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Articles

Instead of addressing API solubility during formulation, tackle it early during development. Read about the various methods for API processing.





Global Trade Item Number

SKUGTIN
1.37000.901004027269240141
1.37000.250004027269063801
1.37000.500004054839369186
1.37000.100004054839369148
1.37000.902504027269061395