Merck
All Photos(3)

1.06143

SAFC

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:
Molecular Weight:
195.21
Beilstein:
385906
MDL number:
EC Index Number:
228-506-9

Agency

ChP
JP
Ph. Eur.
USP

Quality Level

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)

biopharma process and formulation
liquid formulation
parenterals
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 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.

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Quality

Enter Lot Number to search for Certificate of Quality (COQ).

What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials.

Elemental Impurities Information

Available by subscription or for a fee

API Information Package

Available by subscription or for a fee

Learn more about the benefits an Emprove® Program subscription can provide
Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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