ARK2210

Etanolo

API Grade

• Sinonimo/i: Alcol etilico
• Formula condensata: CH₃CH₂OH
• Numero CAS: 64-17-5
• Peso molecolare: 46.07
• Beilstein: 1718733
• Numero MDL: MFCD00003568
• Codice UNSPSC: 12191601
• Numero E: E1510
• Numero indice EU: 603-002-00-5

Proprietà

• Grado: GMP
• Livello qualitativo: 600
• agenzia: Ph. Eur.; USP
• Densità del vapore: 1.59 (vs air)
• Tensione di vapore: 44.6 mmHg ( 20 °C)
• Stato: liquid
• Temp. autoaccensione: 683 °F
• Limite di esplosione: 19 %, 60 °F
• Impurezze: low in endotoxins
• Indice di rifrazione: n20/D 1.3600 (lit.)
• P. ebollizione: 78 °C (lit.)
• Punto di fusione: −114 °C (lit.)
• applicazioni: parenterals; parenterals; pharmaceutical
• Formato: neat
• Temperatura di conservazione: 2-25°C
• Stringa SMILE: CCO
• InChI: 1S/C2H6O/c1-2-3/h3H,2H2,1H3; LFQSCWFLJHTTHZ-UHFFFAOYSA-N

Descrizione

Descrizione generale

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.

Applicazioni

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”.

Confezionamento

ARK2210-1l / Glass Bottle

ARK2210-5l / Stainless Steel Drum

ARK2210-25l / Stainless Steel Drum

ARK2210-100l / Stainless Steel Drum

Nota a piè di pagina

¹La distribuzione e l′uso di alcol etilico in Svizzera richiedono una licenza dalla Amministrazione Federale Svizzera Alcol.

Note legali

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

Informazioni sulla sicurezza

• Pittogrammi: GHS02,GHS07
• Avvertenze: Danger
• Indicazioni di pericolo: H225,H319
• Consigli di prudenza: P210 - P233 - P240 - P241 - P242 - P305 + P351 + P338
• Classi di pericolo: Eye Irrit. 2 - Flam. Liq. 2
• Codice della classe di stoccaggio: 3 - Flammable liquids
• Classe di pericolosità dell'acqua (WGK): WGK 1
• Punto d’infiammabilità (°F): 55.4 °F - closed cup
• Punto d’infiammabilità (°C): 13 °C - closed cup