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
• 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

Disclaimer

The substance 1.06143 has no REACH registration because the only supported use is the use in medicinal products for human or veterinary use or in food or feedingstuffs according to article 2 of the REACH Regulation (EC) No 1907/2006.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable