Agency
ChP
JP
Ph. Eur.
USP
质量水平
产品线
EMPROVE® EXPERT
表单
solid
自燃温度
~662 °F
pH值(酸碱度)
11 (20 °C, 10 g/L in H2O)
沸点
210 °C/1013 hPa
mp
129-131.5 °C (lit.)
应用
liquid formulation
pharmaceutical
solid formulation
solubility enhancement
储存温度
no temp limit
SMILES字符串
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 key
MBBZMMPHUWSWHV-BDVNFPICSA-N
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一般描述
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.
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.
应用
Meglumine Emprove® Essential is a robust pharmaceutical excipient that can provide stability, solubility enhancement and pH modification in solid and liquid formulations.
特点和优势
- 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
法律信息
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
储存分类代码
11 - Combustible Solids
WGK
WGK 1
闪点(°F)
Not applicable
闪点(°C)
Not applicable
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