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Merck

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
暫時無法取得訂價和供貨情況

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


什麼是Emprove® 套裝?

Emprove® 計劃是一個為我們的篩選器和單次用元件、製藥原料和起始材料提供全面徹底記錄的系統。

了解更多效益 Emprove® 計畫訂閱可提供
為什麼沒有這些文件?
Emprove® 檔案包含旨在支持藥品生產商的註冊過程和風險評估活動的訊息,並包含機密資訊。如果您想存取,請聯絡我們

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文章

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.

我們對 API 溶解度與溶解度增強方法的概述,可協助您在製劑過程中的許多選擇中作出決定。

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

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