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Key Documents

1.13126

SAFC

Silicon dioxide

colloidal, highly dispersed, EMPROVE® ESSENTIAL, Ph. Eur., JP, NF, E 551

Pharma Manufacturing

Synonym(s):

Silica, Silicon dioxide

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About This Item

Linear Formula:
SiO2
CAS Number:
Molecular Weight:
60.08
MDL number:
UNSPSC Code:
12352309
E Number:
E551
EC Index Number:
231-545-4

Agency

JP
NF
Ph. Eur.

Quality Level

product line

EMPROVE® ESSENTIAL

form

solid

pH

7 (20 °C, 100 g/L in H2O, slurry)

bp

2230 °C (lit.)

mp

>1600 °C (lit.)

application(s)

liquid formulation
pharmaceutical
semi-solid formulation
solid formulation

storage temp.

15-25°C

SMILES string

O=[Si]=O

InChI

1S/O2Si/c1-3-2

InChI key

VYPSYNLAJGMNEJ-UHFFFAOYSA-N

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General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. 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.

Application

Silicon dioxide is a widely used ingredient in food and pharmaceutical applications. Its application includes the use as a viscosity-increasing agent and emulsion stabilizer in liquid formulations as well as the use as flow regulator or glidant to improve flow properties of dry powders in tablet and capsule manufacturing.

Legal Information

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

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

Precautionary Statements

Hazard Classifications

STOT RE 1 Inhalation

Storage Class Code

6.1D - Non-combustible acute toxic Cat.3 / toxic hazardous materials or hazardous materials causing chronic effects

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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