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1.06143

SAFC

Meglumine

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

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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

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

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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.

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Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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