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Key Documents

Safety Information

1.08117

SAFC

Kieselguhr

purified and calcined, EMPROVE® ESSENTIAL, NF

Pharma Manufacturing

Synonym(s):

Kieselguhr, Diatomaceous earth, Diatomite

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About This Item

CAS Number:
MDL number:
UNSPSC Code:
11101527
EC Index Number:
272-489-0

Agency

NF

Quality Level

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

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

Signal Word

Danger

Hazard Statements

Precautionary Statements

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


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

ISHL Indicated Name

Substances Subject to be Indicated Names

ISHL Notified Names

Substances Subject to be Notified Names


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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