Agency
NF
Ph. Eur.
质量水平
产品线
EMPROVE® EXPERT
形式
solid
分子量
avg mol wt 1387.2 g/mol
pH值(酸碱度)
5.0-7.0 (20 g/L in H2O)
溶解性
450 g/L
应用
liquid formulation
ophthalmics
pharmaceutical
solid formulation
solubility enhancement
储存温度
15-25°C
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
Cyclodextrin HPB (hydroxypylated β-cyclodextrin) can be used to strongly increase solubility of active pharmaceutical ingredients (APIs) by forming API:cyclodextrin inclusion complexes. It can also increase API stability and safety as well as mask undesired odors and tastes. The broad application range of Cyclodextrin HPB comprises liquid, semi-solid and solid formulations, as well as diverse routes of administration. Due to its low microbial and endotoxin limits, Cyclodextrin HPB Emprove® Expert is especially suitable for high-risk applications.
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)
752.0 °F
闪点(°C)
> 400 °C
法规信息
新产品
商品
This overview describes the challenges when developing parenteral formulations and strategies to overcome them and reduce the risk of production.
This article outlines critical factors in long-term stability of proteins, and how different stabilizers protect again mechanical and thermal stress.
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