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1.00986

SAFC

Ethanol

greener alternative

absolute, EMPROVE® EXPERT, Ph. Eur., BP, ChP, JP, USP

Pharma Manufacturing

Synonym(s):

Ethyl alcohol

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About This Item

Linear Formula:
CH3CH2OH
CAS Number:
64-17-5
Molecular Weight:
46.07
Beilstein/REAXYS Number:
1718733
MDL number:
MFCD00003568
UNSPSC Code:
12191502
EC Index Number:
200-578-6

agency

BP
ChP
JP
Ph. Eur.
USP

Quality Level

500

vapor density

1.59 (vs air)

vapor pressure

44.6 mmHg ( 20 °C)
59 hPa ( 20 °C)

product line

EMPROVE® EXPERT

assay

≥99.2% (m/m)

form

liquid

autoignition temp.

683 °F

expl. lim.

19 %, 60 °F

greener alternative product characteristics

Safer Solvents and Auxiliaries
Use of Renewable Feedstocks
Learn more about the Principles of Green Chemistry.

concentration

≥99.5 % (v/v)

technique(s)

API processing | polymorph screening: suitable

refractive index

n20/D 1.3600 (lit.)

pH

7.0 (20 °C, 10 g/L in H2O)

bp

78 °C (lit.)

mp

−114 °C (lit.)

transition temp

flash point 12 °C

density

0.789 g/mL at 25 °C (lit.)

application(s)

liquid formulation
ophthalmics
parenterals
pharma/biopharma processes
pharmaceutical
semi-solid formulation

format

neat

greener alternative category

, Aligned

storage temp.

2-25°C

SMILES string

CCO

InChI

1S/C2H6O/c1-2-3/h3H,2H2,1H3

InChI key

LFQSCWFLJHTTHZ-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.
We are committed to bringing you Greener Alternative Products, which adhere to one or more of The 12 Principles of Green Chemistry. This product is a bio-based ethanol and is aligned with the 5th principle of Green Chemistry "Safer Solvents and Auxiliaries" and 7th principle "Use of Renewable Feedstock". Click here for more information.

Application

Ethanol is used as a solvent in oral, topical, and parenteral formulations.
Due to its low microbial and endotoxin limits, Ethanol absolute Emprove® Expert is especially suitable for high-risk applications.

Footnote

1Distribution and use of ethyl alcohol in Switzerland require a license from the Swiss Federal Alcohol Administration

Legal Information

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

pictograms

FlameExclamation mark
GHS02,GHS07

signalword

Danger

Hazard Classifications

Eye Irrit. 2 - Flam. Liq. 2

Storage Class

3 - Flammable liquids

wgk_germany

WGK 1

flash_point_f

55.4 °F

flash_point_c

13 °C

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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