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SAFC

Parteck® SLC 500

EMPROVE® ESSENTIAL, Ph. Eur., NF

Pharma Manufacturing

Synonym(s):

Silica, colloidal anhydrous silica, colloidal silica, colloidal silicon dioxide, fumed silica, fumed silicon dioxide, highly disperse silicon dioxide, light anhydrous silicic acid, silica, Silicon dioxide

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About This Item

Linear Formula:
SiO2
CAS Number:
7631-86-9
Molecular Weight:
60.08
MDL number:
MFCD00011232
UNSPSC Code:
12352201

Agency

NF
Ph. Eur.

Quality Level

500

product line

EMPROVE® ESSENTIAL

form

fine powder

particle size

17-25 μm (d50)

bp

2230 °C (lit.)

mp

>1600 °C (lit.)
1710 °C

application(s)

pharmaceutical
pharmaceutical
solid formulation
solubility enhancement

storage temp.

2-30°C

SMILES string

O=[Si]=O

InChI

1S/O2Si/c1-3-2

InChI key

VYPSYNLAJGMNEJ-UHFFFAOYSA-N

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General description

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.

Features and Benefits

  • 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

Packaging

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

Legal Information

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

Storage Class Code

13 - Non Combustible Solids

WGK

nwg

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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