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Key Documents

1.20091

SAFC

Silice

EMPROVE® ESSENTIAL, Ph. Eur., NF

Fabrication pharma

Synonyme(s) :

Dioxyde de silicium

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About This Item

Formule linéaire :
SiO2
Numéro CAS:
Poids moléculaire :
60.08
Numéro MDL:
Code UNSPSC :
12352201

Agence

NF
Ph. Eur.

Niveau de qualité

Gamme de produits

EMPROVE® ESSENTIAL

Forme

fine powder

Taille des particules

17-25 μm (d50)

Point d'ébullition

2230 °C (lit.)

Pf

>1600 °C (lit.)
1710 °C

Application(s)

pharmaceutical
pharmaceutical
solid formulation
solubility enhancement

Température de stockage

2-30°C

Chaîne SMILES 

O=[Si]=O

InChI

1S/O2Si/c1-3-2

Clé InChI

VYPSYNLAJGMNEJ-UHFFFAOYSA-N

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Description générale

With formulation challenges in mind, we have used particle engineering technologies to develop functional excipients specifically for solid dosage forms. The products in our Parteck® portfolio feature unique particle properties tailored for excellent performance in tableting processes, for specific drug delivery technologies, or for solubility enhancement. 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

Parteck® SLC excipient is an innovative silica drug carrier that enhances drug solubility thanks to its unique surface structure, which can stabilize the amorphous state. This is especially relevant for poor glass forming APIs, which can be difficult to stabilize with other formulation technologies. Parteck® SLC is also emerging as a first-in-class excipient to reduce the risk of unstable polymorphism and particle properties in drug development. In this application, Parteck® SLC can homogenize both properties in a template-based formulation approach, with robust and reliable results.

Caractéristiques et avantages

  • Solubility enhancement of APIs
  • Unparalleled stabilization of the amorphous solid state
  • Unique pore structure (6 nm diameter) and a very high surface area (500 m²/g)
  • Perfect fit to stabilize poor glass former molecules
  • Platform approach to manage API particle and polymorph variation
  • No specific equipment/extra capital invest needed to stabilize the amorphous form of APIs
  • High-end application support

Conditionnement

1200910300 // Wide necked plastic bottle in corrugated box
1200911000 // Wide necked plastic bottle in corrugated box
1200919025 // Standard PE bag in PE square drum

Informations légales

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

Code de la classe de stockage

13 - Non Combustible Solids

Classe de danger pour l'eau (WGK)

nwg

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


Certificats d'analyse (COA)

Recherchez un Certificats d'analyse (COA) en saisissant le numéro de lot du produit. Les numéros de lot figurent sur l'étiquette du produit après les mots "Lot" ou "Batch".

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Articles

Our overview of API solubility and dissolution enhancement methods can help you decide between the many options to take during formulation.

Our overview of API solubility and dissolution enhancement methods can help you decide between the many options to take during formulation.

Our overview of API solubility and dissolution enhancement methods can help you decide between the many options to take during formulation.

Our overview of API solubility and dissolution enhancement methods can help you decide between the many options to take during formulation.

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