Ethanol API Grade 1 X 1 L

SKU: ARK2210-1L
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Ethanol API Grade 1 X 1 L

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

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

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

API-grade Ethanol, manufactured under cGMP to meet ICH Q7 requirements. Suitable for pharmaceutical drug formulations with patient contact. Used in antiseptics, antidotes, and therapeutic ethanol ablation.

Properties:
• Product Name: Ethanol, absolute EMPLURA®, for preparative purposes
• 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.)
• Applications: parenterals
parenterals
pharmaceutical
• Format: Neat
• Storage temp: 2-25°C
• SMILES string: CCO
• InChl: 1S/C2H6O/c1-2-3/h3H,2H2,1H3
• InChl key: LFQSCWFLJHTTHZ-UHFFFAOYSA-N

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