8.17067

SAFC

Dibutyl sebacate

NF

Synonym(s):
Dibutyl sebacate
Linear Formula:
CH3(CH2)3OOC(CH2)8COO(CH2)3CH3
CAS Number:
Molecular Weight:
314.46
MDL number:
EC Index Number:
203-672-5

storage conditions

Store at +15°C to +25°C.

Agency/Method

NF

Quality Level

vapor pressure

3.99 hPa ( 180 °C)

assay

92.0-102.0% (GC)

potency

14870 mg/kg LD50, oral (Rat)

bp

343 °C/1013 hPa

mp

-11 °C

transition temp

flash point 178 °C

density

0.937 g/cm3 at 20 °C

storage temp.

15-25°C

InChI

1S/C18H34O4/c1-3-5-15-21-17(19)13-11-9-7-8-10-12-14-18(20)22-16-6-4-2/h3-16H2,1-2H3

InChI key

PYGXAGIECVVIOZ-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

Dibutyl sebacate is used as a plasticizer in a variety of oral pharmaceutical formulations, for example in film coatings of tablets, granules, or beads as well as in controlled-release tablets and microcapsule preparations.

Legal Information

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

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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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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