Meglumine: Two grades, Many Applications

Meglumine is a versatile product applied either as a counterion to form a salt with the API or as a functional excipient. Traditionally applied as a counterion in contrast media, meglumine is an organic base which can also be used as a functional excipient to enhance API solubility, improve API stability, and adjust pH value.

Applications include solid and liquid formulations, such as tablets, injectables and ophthalmics, as well as topical dosage forms. Depending on the application, meglumine must meet different regulatory requirements and is therefore provided in API and excipient grade. While Meglumine low in endotoxins EMPROVE® API is ideal when utilized as an advanced API intermediate or counterion, Meglumine EMPROVE® ESSENTIAL is ideal for excipient applications. Both grades are of the same, high quality API-grade but are supported by different EMPROVE® dossiers - tailored for the requirements of their respective applications.

Benefits of our meglumine products

• Solubility and bioavailability enhancement of APIs
• Excellent counterion performance, a viable alternative to sodium
• API grade: manufactured under the cGMP ICH Q7 guideline for APIs
• Sole manufacturing location for API-grade meglumine in Europe
• Multi-compendial product, complying with all major pharmacopeias, including ChP
• Meglumine EMPROVE® API has also been successfully co-reviewed in China