Microsoft word - eumulgin b1 ph.rtf

Product Data Sheet
EUMULGIN® B 1 PH

General characterisation
Chemical description
Cetyl stearyl alcohol with 12 mol EO
Labeling information
INCI name(s)
Ceteareth-12
Composition hints for finished product label
Ceteareth-12
Registrations

Ingredient CASR-No.
EINECS/ELINCS-No.

Officially listed in / Quality conforms to
Ph. Eur.:
Conforms to the current analytical specification in the monograph "Macrogoli aether cetostearylicus (Macrogol cetostearyl ether)" Conforms to the current analytical specification in the monograph "Macrogol cetostearyl ether" (copy of the Ph. Eur. Monograph) Conforms to current ICH Guideline (CPMP/ICH/283/95). encephalopathy agents
Product properties
Appearance
EUMULGIN® B 1 PH is a white, wax-like mass with a mild odour delivered in pellets.
Example of use
The product can be universally applied as a non-ionic emulsifier for pharmaceutical O/ W emulsions.
Characteristic values
The specifications stated in the paragraphs 'Quality control data' and 'Additional product descriptive data' finally and conclusively describe the properties of the Product.
Quality control data
(Data which is used for quality release and is certified for each batch.)
Appearance (colour)
Further certification: Pesticide residues complies to the limits defined in Ph. Eur. 2.8.13 (table 1). complies with criteria defined in Ph. Eur. 5.1.4 (catagory 2 - topical applications; catagory 3A - oral applications). conforms to German ordinance requirements regulating aflatoxine conforms to German Federal Health Gazette 28, 216 1985 and
Methods of identification
As described in the current Monograph of the Ph. Eur.
Methods of analysis
All test and assay methods are as described in the current Monograph of the Ph. Eur.
Storage and transportation
In the original sealed containers the product can be stored for at least two years, protected from moisture at
below 30°C. Depending on the temperature, the pH value may decrease during storage. However, the product
quality is not negatively influenced above a pH value of 4.0.

Revision-No. 3-06.2004
All products in the text marked with an ® are trademarks of the Cognis group.
Suggestions for processing and use of our products as well as possible formulation suggestions are provided noncommittally in accordance with our knowledge and information. They do not discharge our customers from testing the products on suitability for processes and purposes they are destined for. We are only liable for a damage caused intentionally or by gross negligence. However, we are under no circumstances liable for consequential damage. Each processor is liable for the compliance of all legal regulations, including patent Cognis does not guarantee the suitability of a product for a user-specific purpose.

Source: http://www.cospha.ro/dbimg/Eumulgin%20B1%20PH.pdf