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SPEZIOL® L2SM GS PHARMA

SPEZIOL® L2SM GS PHARMA

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SPEZIOL® <strong>L2SM</strong> <strong>GS</strong> <strong>PHARMA</strong>(Ph.Eur.: "Stearic Acid 50"BP: "Stearic Acid 50"NF: "Stearic Acid")General characterisationChemical descriptionStearic-/Palmitic AcidLabeling informationINCI name(s)Stearic Acid (and) Palmitic AcidRegistrationsIngredient CASR-No. EINECS/ELINCS-No.67701-03-5 266-928-5Officially listed in / Quality conforms toPh.Eur.:BP:USP / NF :US DMF no. (Typ IV): #17763Conforms to the current analytical specification in the monograph"Stearic Acid 50"Conforms to the current analytical specification in the monograph"Stearic Acid 50" (copy of the Ph. Eur. Monograph)Conforms to the current analytical specification in the monograph"Stearic Acid"Residual solventsConforms to current ICH Guideline (CPMP/ICH/283/95).Minimising animal spongiform Conforms to requirements Ph. Eur. 5.2.8encephalopathy agentsProduct propertiesAppearanceSPEZIOL® <strong>L2SM</strong> <strong>GS</strong> <strong>PHARMA</strong> is a vegetable based Stearic-/Palmitic Acid and white with typicalodour.Example of useOn account of its consistency giving characteristics the product is mainly used for viscosity regulationin pharmaceutical O/W-emulsions.Characteristic valuesThe specifications stated in the paragraphs 'Quality control data' and 'Additional product descriptivedata' 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.)Ph.Eur.IdentityAppearance of solutionAcidityconformsconformsconforms21.08.2006 SPEZIOL_r_<strong>L2SM</strong>_<strong>GS</strong>_<strong>PHARMA</strong>_E 1


Acid value 194 – 212Iodine value


Stabilising additives / Auxiliaries(type and concentration)Preservativesnot presentAntioxidantsnot presentSolventsnot presentOthersnot presentStorage and transportationIn the original sealed containers SPEZIOL® <strong>L2SM</strong> <strong>GS</strong> <strong>PHARMA</strong> can be stored for at least two years,protected from moisture at below 40°C. During storage curdles can occur.Revision-No. 3-06.2004All products in the text marked with an ® are trademarks of the Cognis group.The information on product specifications provided herein is only binding to the extent confirmed by Cognis in a written SalesAgreement. COGNIS EXPRESSLY DISCLAIMS ANY RESPONSIBILITY FOR THE SUITABILITY OF THE PRODUCTS FOR ANYSPECIFIC OR PARTICULAR PURPOSES INTENDED BY THE USER. Suggestions for the use and application of the products andguide formulations are given for information purposes only and without commitment. Such suggestions do not release Cognis´customers from testing the products as to their suitability for the customer’s intended processes and purposes. Cognis does notassume any liability or risk involved in the use of its products as the conditions of use are beyond its control. The user of theproducts is solely responsible for compliance with all laws and regulations applying to the use of the products, including intellectualproperty rights of third parties.21.08.2006 SPEZIOL_r_<strong>L2SM</strong>_<strong>GS</strong>_<strong>PHARMA</strong>_E 3

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