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Merck
CN

ARK2210

Ethanol

API Grade

Synonym(s):

Absolute Alcohol, Alcohol, EtOH, Ethanol - API Grade, Ethyl Alcohol, Ethyl Hydrate, Ethyl Hydroxide, Ethylic Alcohol, Hydroxyethane, Ethyl alcohol

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About This Item

Linear Formula:
CH3CH2OH
CAS Number:
64-17-5
Molecular Weight:
46.07
UNSPSC Code:
12191601
EC Index Number:
603-002-00-5
E Number:
E1510
MDL number:
MFCD00003568
Beilstein/REAXYS Number:
1718733

Key Documents

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Product Name

Ethanol, API Grade

InChI

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

SMILES string

CCO

InChI key

LFQSCWFLJHTTHZ-UHFFFAOYSA-N

grade

GMP

agency

Ph. Eur.
USP

vapor density

1.59 (vs air)

vapor pressure

44.6 mmHg ( 20 °C)

form

liquid

autoignition temp.

683 °F

expl. lim.

19 %, 60 °F

impurities

low in endotoxins

refractive index

n20/D 1.3600 (lit.)

bp

78 °C (lit.)

mp

−114 °C (lit.)

application(s)

parenterals
parenterals
pharmaceutical

format

neat

storage temp.

2-25°C

Quality Level

600

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Application

Ethanol is used in some drug product formulations where the Ethanol has a pharmacological effect and has direct patient contact or contact with other substances with direct patient contact. In these cases, there is a need for Ethanol which is fully compliant with ICH Q7 GMP requirements for APIs.
Our Ethanol API supports our customers with their final drug product compliance. The drug products containing Ethanol API are used for example as antiseptic agents and antidotes, as well as for alcohol septal ablation to treat cardiomyopathy and several oncology applications like “Alcoholneurolysis”, “Ethanol Ablation of Hepatocellular Carcinoma” and “Percutaneous ethanol ablation”.

General description

Searching for an API that’s right for you? Our high-quality APIs provide all the necessary regulatory information for your needs. We offer best-practice support throughout your entire registration process and boast an excellent track record facilitating our customers’ compliance with international standards – making us your preferred global partner for APIs.
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.

Other Notes

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

Packaging

ARK2210-1l / Glass Bottle

ARK2210-5l / Stainless Steel Drum

ARK2210-25l / Stainless Steel Drum

ARK2210-100l / Stainless Steel Drum

Legal Information

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

pictograms

FlameExclamation mark
GHS02,GHS07

signalword

Danger

hcodes

H225,H319

Hazard Classifications

Eye Irrit. 2 - Flam. Liq. 2

Storage Class

3 - Flammable liquids

wgk

WGK 1

flash_point_f

55.4 °F - closed cup

flash_point_c

13 °C - closed cup

Regulatory Information

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