1.06187

N-Méthyle-D-glucamine

EMPROVE^® EXPERT, Ph. Eur., ChP, JP, USP

• Synonyme(s) : 1-Désoxy-1-(méthylamino)-D-glucitol, Méglumine
• Formule empirique (notation de Hill): C₇H₁₇NO₅
• Numéro CAS: 6284-40-8
• Poids moléculaire : 195.21
• Beilstein: 385906
• Numéro MDL: MFCD00004707
• Code UNSPSC : 12352104
• Numéro de classement CE : 228-506-9

Propriétés

• Agence: ChP; JP; Ph. Eur.; USP
• Niveau de qualité: 500
• Gamme de produits: EMPROVE^® EXPERT
• Forme: solid
• Température d'inflammation spontanée: ~662 °F
• pH: 11 (20 °C, 10 g/L in H₂O)
• pb: 210 °C/1013 hPa
• Pf: 129-131.5 °C (lit.)
• Application(s): liquid formulation; pharmaceutical; solid formulation; solubility enhancement
• Température de stockage: no temp limit
• Chaîne SMILES: CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO
• InChI: 1S/C7H17NO5/c1-8-2-4(10)6(12)7(13)5(11)3-9/h4-13H,2-3H2,1H3/t4-,5+,6+,7+/m0/s1
• Clé InChI: MBBZMMPHUWSWHV-BDVNFPICSA-N

Description

Description générale

When working on a pharmaceutical formulation, there are specific considerations to make and challenging hurdles to take before you can successfully launch your final drug product - formulation stability, release kinetics and bioavailability limitations just to name a few. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our Emprove^® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. 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

Meglumine Emprove^® Essential is a robust pharmaceutical excipient that can provide stability, solubility enhancement and pH modification in solid and liquid formulations.

Caractéristiques et avantages

• 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

Informations légales

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

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

Informations sur la sécurité

• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 1
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable