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Merck
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文件

1.06187

SAFC

葡甲胺

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

製藥生產

同義詞:

N -甲基- D -葡胺, 1-去氧-1-(甲胺)-D-山梨醇, 葡甲胺

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About This Item

經驗公式(希爾表示法):
C7H17NO5
CAS號碼:
分子量::
195.21
Beilstein:
385906
MDL號碼:
分類程式碼代碼:
12352104
酶委員會索引編號:
228-506-9

agency

ChP
JP
Ph. Eur.
USP

品質等級

產品線

EMPROVE® EXPERT

形狀

solid

自燃溫度

~662 °F

pH值

11 (20 °C, 10 g/L in H2O)

bp

210 °C/1013 hPa

mp

129-131.5 °C (lit.)

應用

liquid formulation
pharmaceutical
solid formulation
solubility enhancement

儲存溫度

no temp limit

SMILES 字串

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 密鑰

MBBZMMPHUWSWHV-BDVNFPICSA-N

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一般說明

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.

應用

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

特點和優勢

  • 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

法律資訊

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

儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 1

閃點(°F)

Not applicable

閃點(°C)

Not applicable


分析證明 (COA)

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