1.00986

SAFC

Ethanol

absolute suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,USP

Synonym(s):
Ethyl alcohol
Linear Formula:
CH3CH2OH
CAS Number:
Molecular Weight:
46.07
Beilstein/REAXYS Number:
1718733
MDL number:
EC Index Number:
200-578-6

storage conditions

Store at +5°C to +30°C.

Quality Level

Agency/Method

BP
JP
Ph. Eur.
USP

vapor density

1.59 (vs air)

vapor pressure

44.6 mmHg ( 20 °C)
59 hPa ( 20 °C)

product line

EMPROVE® Exp

assay

≥99.2% (m/m)
≥99.5% (v/v)

form

liquid

autoignition temp.

683 °F

potency

6200 mg/kg LD50, oral (Rat)

expl. lim.

19 %, 60 °F

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.)

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.

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

Certificate of Analysis

Certificate of Origin

What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials.

Material Qualification Dossier

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Quality Management Dossier

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Operational Excellence Dossier

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Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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