1.00661

SAFC

Parteck® LUB STA 50

(Stearic acid 50 vegetable grade), EMPROVE® ESSENTIAL, Ph. Eur., BP, JP, NF

Synonym(s):
Fatty acids C16-18, Stearic acid - palmitic acid mixture, Palmitic acid – stearic acid mixture
CAS Number:
Beilstein/REAXYS Number:
608585
MDL number:

storage conditions

Store at +15°C to +25°C.

Quality Level

Agency/Method

BP
JP
NF
Ph. Eur.

product line

EMPROVE® ESSENTIAL

assay

≥90% (stearic acid and palmitic acid, GC)

form

solid

autoignition temp.

395 °C

potency

>5000 mg/kg LD50, oral (Rat)
>5000 mg/kg LD50, skin (Rabbit)

particle size

5 μm

bp

370 °C/1013 hPa

mp

68-70 °C

transition temp

flash point 196 °C

bulk density

400‑500 kg/m3

cation traces

Ni: ≤1 ppm
heavy metals (as Pb): ≤20 ppm

storage temp.

15-25°C

SMILES string

CCCCCCCCCCCCCCCCCC(O)=O

InChI

1S/C18H36O2/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20/h2-17H2,1H3,(H,19,20)

InChI key

QIQXTHQIDYTFRH-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.
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

Parteck® LUB, a product line of our most effective excipients for lubrication, demonstrates excellent batch-to-batch consistency and helps you to achieve a reliable workflow in your tablet manufacture. Parteck® LUB STA 50 is a vegetable-origin stearic acid.

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 Germany

nwg

Flash Point F

Not applicable

Flash Point C

Not applicable

Certificate of Analysis

Certificate of Origin

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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Quality Management 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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