产品名称
酒精, 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
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Other Notes
1在瑞士分发和使用乙醇需要瑞士联邦酒精管理局的许可证。
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”.
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.
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.
Packaging
ARK2210-1l / Glass Bottle
ARK2210-5l / Stainless Steel Drum
ARK2210-25l / Stainless Steel Drum
ARK2210-100l / Stainless Steel Drum
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
signalword
Danger
hcodes
Hazard Classifications
Eye Irrit. 2 - Flam. Liq. 2
存储类别
3 - Flammable liquids
wgk
WGK 1
flash_point_f
55.4 °F - closed cup
flash_point_c
13 °C - closed cup
法规信息
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