Merck
All Photos(2)

1.05006

SAFC

Bole white

powder, low bacterial content, for internal use, EMPROVE® ESSENTIAL, Ph. Eur., BP

Synonym(s):
Bole white
CAS Number:
EC Index Number:
310-194-1

Agency

BP
Ph. Eur.

Quality Level

product line

EMPROVE® ESSENTIAL

form

powder
solid

pH

6-7 (20 °C, 50 g/L in H2O, slurry)

density

2.6 g/cm3 at 20 °C

application(s)

pharmaceutical
semi-solid formulation
solid formulation

storage temp.

2-30°C

InChI

1S/2Al.O5Si2.2H2O.2O/c;;1-6(2)5-7(3)4;;;;/h;;;2*1H2;;/q2*+1;-2;;;;

InChI key

NLYAJNPCOHFWQQ-UHFFFAOYSA-N

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This Item
1.04440K7375K1512
Bole white powder, low bacterial content, for internal use, EMPROVE® ESSENTIAL, Ph. Eur., BP

SAFC

1.05006

Bole white

Kaolin powder

Supelco

1.04440

Kaolin

Kaolin

Sigma-Aldrich

K7375

Kaolin

Kaolin meets USP testing specifications

Sigma-Aldrich

K1512

Kaolin

form

powder, solid

form

-

form

powder

form

solid

pH

6-7 (20 °C, 50 g/L in H2O, slurry)

pH

6-7 (20 °C, 50 g/L in H2O, slurry)

pH

3.5-5.0 (20% in water)

pH

-

density

2.6 g/cm3 at 20 °C

density

2.6 g/cm3 at 20 °C

density

-

density

-

Quality Level

500

Quality Level

100

Quality Level

200

Quality Level

200

agency

BP

agency

-

agency

-

agency

USP/NF, meets USP testing specifications

product line

EMPROVE® ESSENTIAL

product line

-

product line

-

product line

-

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

Bole white (synonym kaolin) is a commonly used ingredient in both food and pharmaceutics. In pharmaceutical applications, bole white has been used primarily for solid oral dosage forms as well as topical formulations.

Legal Information

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

Storage Class Code

11 - Combustible Solids

WGK

nwg

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials.

Material Qualification Dossier

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Operational Excellence Dossier

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Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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