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1.06187

SAFC

Meglumine

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

Pharma Manufacturing

Synonym(s):

N-Methyl-D-glucamine, 1-Deoxy-1-methylaminosorbitol, 1-Deoxy-1-methylaminosorbitol, 1-Deoxy-1-(methylamino)-D-glucitol, Meglumine

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About This Item

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

Agency

ChP
JP
Ph. Eur.
USP

Quality Level

500

product line

EMPROVE® EXPERT

form

solid

autoignition temp.

~662 °F

pH

11 (20 °C, 10 g/L in H2O)

bp

210 °C/1013 hPa

mp

129-131.5 °C (lit.)

application(s)

liquid formulation
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

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

Features and Benefits

  • 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

Legal Information

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

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Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

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