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1.06143

N-メチル-D-グルカミン

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

別名:

1-デオキシ-1-（メチルアミノ）-D-グルシトール, メグルミン

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この商品について

実験式（ヒル表記法）:
C7H17NO5
CAS番号:
6284-40-8
分子量:
195.21
EC Index Number:
228-506-9
UNSPSC Code:
12352104
Beilstein/REAXYS Number:
385906
MDL number:
MFCD00004707
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Quality Level

600

agency

ChP, JP, Ph. Eur., USP

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

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

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保管分類

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

試験成績書（COA）

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資料

Liquid Formulation Solubility Enhancement

Discover strategies to enhance solubility in injectable formulations using excipients, including cyclodextrins, meglumine, and polyethylene glycols.

Improving API Solubility using API Processing

Instead of addressing API solubility during formulation, tackle it early during development. Read about the various methods for API processing.

関連コンテンツ

Successfully Navigate the Regulatory Landscape for Chemicals and Single-Use Consumables

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.

APIs Tailored to Your Needs.
Double your benefit with meglumine
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グローバルトレードアイテム番号

カタログ番号GTIN
1.06143.902504022536073279
1.06143.100004022536073262