1.06187

N-metil-D-glucamina

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

• Sinonimo/i: 1-desossi-1-(metilamino)-D-glucitolo, Meglumina
• Formula empirica (notazione di Hill): C₇H₁₇NO₅
• Numero CAS: 6284-40-8
• Peso molecolare: 195.21
• Beilstein: 385906
• Numero MDL: MFCD00004707
• Codice UNSPSC: 12352104
• Numero indice EU: 228-506-9

Proprietà

• agenzia: ChP; JP; Ph. Eur.; USP
• Livello qualitativo: 500
• Nome Commerciale: EMPROVE^® EXPERT
• Forma fisica: solid
• Temp. autoaccensione: ~662 °F
• pH: 11 (20 °C, 10 g/L in H₂O)
• P. eboll.: 210 °C/1013 hPa
• Punto di fusione: 129-131.5 °C (lit.)
• applicazioni: liquid formulation; pharmaceutical; solid formulation; solubility enhancement
• Temperatura di conservazione: no temp limit
• Stringa SMILE: 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; MBBZMMPHUWSWHV-BDVNFPICSA-N

Descrizione

Descrizione generale

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.

Applicazioni

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

Caratteristiche e vantaggi

• 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

Note legali

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

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

Informazioni sulla sicurezza

• Codice della classe di stoccaggio: 11 - Combustible Solids
• Classe di pericolosità dell'acqua (WGK): WGK 1
• Punto d’infiammabilità (°F): Not applicable
• Punto d’infiammabilità (°C): Not applicable