8.17003

SAFC

Polyethylene glycol 400

EMPROVE® ESSENTIAL Ph Eur,JP

Synonym(s):
Polyglycol, Polyethylene oxide, Polyoxy ethylene, PEG 400, PEG, Poly(ethylene glycol)
Linear Formula:
H(OCH2CH2)nOH
CAS Number:
MDL number:
EC Index Number:
500-038-2

storage conditions

Store at +15°C to +25°C.

Quality Level

Agency/Method

JP
Ph. Eur.

vapor pressure

<0.1 hPa ( 20 °C)

product line

EMPROVE® ESSENTIAL

autoignition temp.

360 °C (DIN 51794)

potency

28000 mg/kg LD50, oral (Rat)
>20000 mg/kg LD50, skin (Rabbit)

pH

5-7 (20 °C, 100 g/L in H2O)

kinematic viscosity

97-110 cSt(20 °C)

mp

5 °C

transition temp

flash point >200 °C

density

1.13 g/cm3 at 20 °C

storage temp.

15-25°C

SMILES string

C(CO)O

InChI

1S/C2H6O2/c3-1-2-4/h3-4H,1-2H2

InChI key

LYCAIKOWRPUZTN-UHFFFAOYSA-N

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General description

When working on a pharmaceutical formulation, there are specific considerations to make and challenging hurdles to take before you can successfully launch your final drug product - formulation stability, release kinetics and bioavailability limitations just to name a few. 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

Polyethylene glycol (PEG) is a multipurpose polymer which can be applied in solid, semi-solid and liquid formulations. Its broad functional spectrum includes e.g. improvement of API solubility, acting as a lubricant for tablet coating, function as a carrier, and many more. Our comprehensive portfolio of PEGs comprises diverse polymer sizes of different molecular weights to meet your specific application and needs.

Legal Information

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

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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