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