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Merck

1.06143

SAFC

Meglumine

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

Pharma Manufacturing

Synonym(s):

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

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250 MG
₩304,399

₩304,399


Estimated to ship onFebruary 14, 2025Details


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250 MG
₩304,399

About This Item

Empirical Formula (Hill Notation):
C7H17NO5
CAS Number:
Molecular Weight:
195.21
Beilstein:
385906
MDL number:
UNSPSC Code:
12352104
EC Index Number:
228-506-9

₩304,399


Estimated to ship onFebruary 14, 2025Details


Request a Bulk OrderRequest a Sample

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.)

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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

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

1061439025:
1061430000:
1061430001:
CO1E1061431000:
CO1E1061439025:
1.06143.1000.BWT:
1061439029:
MX11061431000:
1061439030:
CO1I1061431000:
1061430500:
1061431000:
1061439050:
1061439026:
1061439025BWT:
1061439999:
CO1I1061439025:


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. Four document types are included with an Emprove® Program subscription:

Elemental Impurities Information

Available by subscription or for a fee

API Information Package

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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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Related Content

This page summarizes key considerations related to regulatory expectations for biomanufacturing including chemicals and polymeric materials. For chemicals, topics include nitrosamines and elemental impurities, and for polymeric materials such as filters and single-use assemblies, the focus is qualification and extractable and leachable testing.

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