ARK2210

Etanol

API Grade

• Sinónimos: Alcohol etílico
• Fórmula lineal: CH₃CH₂OH
• Número de CAS: 64-17-5
• Peso molecular: 46.07
• Beilstein/REAXYS Number: 1718733
• MDL number: MFCD00003568
• UNSPSC Code: 12191601
• E Number: E1510
• EC Index Number: 603-002-00-5

Propiedades

• 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.: 2-25°C
• SMILES string: CCO
• InChI: 1S/C2H6O/c1-2-3/h3H,2H2,1H3
• InChI key: LFQSCWFLJHTTHZ-UHFFFAOYSA-N

Descripción

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

¹La distribución y el uso del alcohol etílico en Suiza requiere una autorización de la Swiss Federal Alcohol Administration

Legal Information

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

Información de seguridad

• pictograms: GHS02,GHS07
• signalword: Danger
• hcodes: H225,H319
• pcodes: P210 - P233 - P240 - P241 - P242 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - Flam. Liq. 2
• Storage Class: 3 - Flammable liquids
• wgk_germany: WGK 1
• flash_point_f: 55.4 °F - closed cup
• flash_point_c: 13 °C - closed cup