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SAFC

Kieselguhr

purified and calcined, EMPROVE® ESSENTIAL, NF

Pharma Manufacturing

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Synonym(s):
Kieselguhr, Diatomaceous earth, Diatomite
CAS Number:
68855-54-9
MDL number:
MFCD00132803
UNSPSC Code:
11101527
EC Index Number:
272-489-0

Agency

NF

Quality Level

500

product line

EMPROVE® ESSENTIAL

form

solid

pH

10 (20 °C, 100 g/L in H2O)

mp

>450 °C

solubility

0.0037 g/L

density

2.36 g/cm3 at 20 °C

application(s)

liquid formulation
pharmaceutical
solid formulation

storage temp.

15-25°C

InChI

1S/C4H9.Li/c1-3-4-2;/h1,3-4H2,2H3;

InChI key

MZRVEZGGRBJDDB-UHFFFAOYSA-N

Related Categories

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

Kieselguhr purified and calcined Emprove® Essential is mainly used in highly regulated pharmaceutical applications in oral administration.

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
GHS08

Signal Word

Danger

Hazard Statements

H372

Precautionary Statements

P260 - P264 - P270 - P314 - P501

Hazard Classifications

STOT RE 1 Inhalation

Target Organs

Lungs

Storage Class Code

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

WGK

WGK 1

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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