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Key Documents

1.00989

SAFC

Cetyl alcohol

EMPROVE® ESSENTIAL, Ph. Eur., BP, JP, NF

Pharma Manufacturing

Synonym(s):

Cetyl alcohol, 1-Hexadecanol

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About This Item

Linear Formula:
CH3(CH2)15OH
CAS Number:
Molecular Weight:
242.44
MDL number:
UNSPSC Code:
12191502
EC Index Number:
253-149-0

Agency

BP
JP
NF
Ph. Eur.

Quality Level

vapor pressure

<1 hPa ( 20 °C)

product line

EMPROVE® ESSENTIAL

Assay

≥96% (GC)
90.0-102.0% (GC)

form

solid

autoignition temp.

235 °C (DIN 51794)

bp

305-330 °C/1013 hPa

mp

46-52 °C

transition temp

flash point 155 °C (DIN 51758)

solubility

<0.0001 g/L

density

0.82 g/cm3 at 50 °C

application(s)

liquid formulation
ophthalmics
pharmaceutical
semi-solid formulation

storage temp.

2-30°C

InChI

1S/C16H34O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17/h17H,2-16H2,1H3

InChI key

BXWNKGSJHAJOGX-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

Cetyl alcohol is used in a wide variety of pharmaceutical formulations, including the application as coating agent in tablet coatings and as emulsifying and stiffening agent in 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


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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