ARK2210

Ethanol

API Grade

• Synonym(s): Absolute Alcohol, Alcohol, EtOH, Ethanol - API Grade, Ethyl Alcohol, Ethyl Hydrate, Ethyl Hydroxide, Ethylic Alcohol, Hydroxyethane, Ethyl alcohol
• Linear Formula: CH₃CH₂OH
• CAS Number: 64-17-5
• Molecular Weight: 46.07
• Beilstein: 1718733
• MDL number: MFCD00003568
• UNSPSC Code: 12191601
• E Number: E1510
• EC Index Number: 603-002-00-5

Properties

• grade: GMP
• Quality Level: 600
• 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.)
• density: 0.789 g/mL at 25 °C (lit.)
• application(s): parenterals; parenterals; pharmaceutical
• format: neat
• storage temp.: no temp limit
• SMILES string: CCO
• InChI: 1S/C2H6O/c1-2-3/h3H,2H2,1H3
• InChI key: LFQSCWFLJHTTHZ-UHFFFAOYSA-N

Description

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.

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”.

Packaging

ARK2210-1l / Glass Bottle

ARK2210-5l / Stainless Steel Drum

ARK2210-25l / Stainless Steel Drum

ARK2210-100l / Stainless Steel Drum

Footnote

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

Legal Information

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

Safety Information

• Pictograms: GHS02,GHS07
• Signal Word: Danger
• Hazard Statements: H225 - H319
• Precautionary Statements: P210 - P233 - P240 - P241 - P242 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - Flam. Liq. 2
• Storage Class Code: 3 - Flammable liquids
• WGK: WGK 1
• Flash Point(F): 55.4 °F
• Flash Point(C): 13 °C