1.06143

Meglumine

low in endotoxins, EMPROVE^® API, Ph. Eur., ChP, JP, USP

• Synonym(s): N-Methyl-D-glucamine, 1-Deoxy-1-methylaminosorbitol, 1-Deoxy-1-(methylamino)-D-glucitol, Meglumine
• Empirical Formula (Hill Notation): C₇H₁₇NO₅
• CAS Number: 6284-40-8
• Molecular Weight: 195.21
• Beilstein: 385906
• MDL number: MFCD00004707
• UNSPSC Code: 12352104
• EC Index Number: 228-506-9

Properties

• Agency: ChP; JP; Ph. Eur.; USP
• Quality Level: 600
• product line: EMPROVE^® API
• form: extra fine powder; solid
• autoignition temp.: ~662 °F
• potency: >5000 mg/kg LD₅₀, oral (Rat)
• technique(s): API processing | salt formation: suitable
• pH: 11 (20 °C, 10 g/L in H₂O)
• bp: 210 °C/1013 hPa (decomposes)
• mp: 129-131.5 °C (lit.)
• application(s): liquid formulation; parenterals; pharma/biopharma processes; pharmaceutical; solid formulation; solubility enhancement
• storage temp.: no temp limit
• SMILES string: 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
• InChI key: MBBZMMPHUWSWHV-BDVNFPICSA-N

Description

General description

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 API grade is a high-quality advanced intermediate that can be directly incorporated as a co-former in API formulations.
Meglumine Emprove^® API is manufactured according to ICH Q7 guidelines.

Legal Information

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

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

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable