Quality Segment
agency
NF, Ph. Eur.
product line
EMPROVE® EXPERT
form
solid
mol wt
avg mol wt 1387.2 g/mol
pH
5.0-7.0 (20 g/L in H2O)
solubility
450 g/L
application(s)
liquid formulation
ophthalmics
pharmaceutical
solid formulation
solubility enhancement
storage temp.
15-25°C
General description
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.
Application
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.
Legal Information
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
저장 등급
11 - Combustible Solids
wgk
WGK 1
flash_point_c
> 400 °C
flash_point_f
>752.0 °F
Emprove® 프로그램을 사용하여 GMP 준수 유지
Emprove® Dossiers로 자격을 가속화하고, 규정 준수를 유지하며, 시간을 절약하세요.
Dossiers 다운로드
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