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Safety Information

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:
36653-82-4
Molecular Weight:
242.44
MDL number:
MFCD00004760
UNSPSC Code:
12191502
EC Index Number:
253-149-0

Agency

BP
JP
NF
Ph. Eur.

Quality Level

500

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

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

1009891000BWT:
1009899024:
1.00989.9024.BWT:
1009890000:
1009891000:
CO1E1009891000:
CO1E1009899024:

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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