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Merck

1.06143

Meglumine

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

동의어(들):

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

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크기 선택

제품정보 (DICE 배송 시 비용 별도)

실험식(Hill 표기법):
C7H17NO5
CAS 번호:
6284-40-8
Molecular Weight:
195.21
EC Index Number:
228-506-9
UNSPSC Code:
12352104
Beilstein/REAXYS Number:
385906
MDL number:
MFCD00004707

주요 문서

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제품 이름

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

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

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

Quality Level

600

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관련 카테고리

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.

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.

Legal Information

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

저장 등급

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

시험 성적서(COA)

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문서 라이브러리 방문

문서

Liquid Formulation Solubility Enhancement

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

관련 콘텐츠

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.

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국제 무역 품목 번호

SKUGTIN
1.06143.100004022536073262
1.06143.902504022536073279

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