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Merck

1.06187

SAFC

Meglumine

EMPROVE® EXPERT, Ph. Eur., ChP, JP, USP

의약품 제조

동의어(들):

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

로그인조직 및 계약 가격 보기


About This Item

실험식(Hill 표기법):
C7H17NO5
CAS Number:
Molecular Weight:
195.21
Beilstein:
385906
MDL number:
UNSPSC 코드:
12352104
EC 인덱스 번호:
228-506-9

Agency

ChP
JP
Ph. Eur.
USP

Quality Level

제품 라인

EMPROVE® EXPERT

형태

solid

autoignition temp.

~662 °F

pH

11 (20 °C, 10 g/L in H2O)

bp

210 °C/1013 hPa

mp

129-131.5 °C (lit.)

응용 분야

liquid formulation
pharmaceutical
solid formulation
solubility enhancement

저장 온도

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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일반 설명

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.

애플리케이션

Meglumine Emprove® Essential is a robust pharmaceutical excipient that can provide stability, solubility enhancement and pH modification in solid and liquid formulations.

특징 및 장점

  • Solubility and bioavailability enhancement of APIs
  • Excellent counterion performance, a viable alternative to sodium
  • API grade: manufactured under the cGMP ICH Q7 guideline for APIs
  • Sole manufacturing location for API-grade meglumine in Europe
  • Multi-compendial product, complying with all major pharmacopeias, including ChP
  • Meglumine Emprove® API has also been successfully co-reviewed in China

법적 정보

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


시험 성적서(COA)

제품의 로트/배치 번호를 입력하여 시험 성적서(COA)을 검색하십시오. 로트 및 배치 번호는 제품 라벨에 있는 ‘로트’ 또는 ‘배치’라는 용어 뒤에서 찾을 수 있습니다.

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문서 라이브러리 방문

문서

This overview describes the challenges when developing parenteral formulations and strategies to overcome them and reduce the risk of production.

Our overview of API solubility and dissolution enhancement methods can help you decide between the many options to take during formulation.

This article describes the use of excipients to help address API stability issues.

자사의 과학자팀은 생명 과학, 재료 과학, 화학 합성, 크로마토그래피, 분석 및 기타 많은 영역을 포함한 모든 과학 분야에 경험이 있습니다..

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