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SILFAR® 1000

$SILFAR<sup>®</sup> 1000

SILFAR® 1000 is a polydimethylsiloxane obtained by hydrolysis and polycondensation of dichlorodimethylsilane and chlorotrimethylsilane. The degree of polymerization (n) is such that the mean kinematic viscosity is 1000mm²/s at 25°C.



特性

Regulatory status

 

Use as pharmaceutical excipient:

SILFAR® 1000 complies with the requirements set down in the monographs Dimeticone (EP) and "Dimethicone" (USP / NF). Wacker explicitly rules out the use of SILFAR® 1000 for parenteral applications.

 

Direct Food additive:

SILFAR® 1000 is listed in the Regulation (EC) No 1333/2008 Annex II and III as amended by Regulations (EU) Nos 1129/2011 and 1130/2011 as E 900 polydimethylsiloxane. It meets the purity requirements as laid down in Regulation (EU) No. 231/2012 and is therefore approved as direct food additive within the EC under observance of the use restrictions in force for polydimethylsiloxane (E 900). SILFAR® 1000 is certified according to HACCP principles. Hence, it meets the requirements on food hygiene in accordance with Regulation (EC) No. 852/2004.

 

Food Contact:

SILFAR® 1000 complies with the Recommendation "XV Silicones" of the BfR concerning the manufacture of essential commodities that have contact with food.

 

SILFAR® 1000 is listed under PM-Nr. 76721 in Regulation (EU) No. 10/2011 as an additive for plastic materials to come into contact with food and meets the specifications under column (4) and (10). The product is not subject to a specific migration limit (SML).

 

SILFAR® 1000 is suitable for use under FDA 21 CFR as follows:

 

§175.105 (ADHESIVES),

§175.300 (RESINOUS AND POLYMERIC COATINGS),

§176.170 (COMPONENTS OF PAPER AND PAPERBOARD IN CONTACT WITH AQUEOUS AND FATTY FOODS)

§176.180 (COMPONENTS OF PAPER AND PAPERBOARD IN CONTACT WITH DRY FOOD).

§176.200 (DEFOAMING AGENTS USED IN COATINGS)

§176.210 (DEFOAMING AGENTS USED IN THE MANUFACTURE OF PAPER AND PAPERBOARD)

§177.1210 (CLOSURES WITH SEALING GASKETS FOR FOOD CONTAINERS).

§177.2800 (TEXTILES AND TEXTILE FIBERS).

§178.3120 (ANIMAL GLUE).

§178.3570 (LUBRICANTS WITH INCIDENTAL FOOD CONTACT)

§178.3910 (SURFACE LUBRICANTS USED IN THE MANUFACTURE OF METALLIC ARTICLES)

§181.28 (RELEASE AGENTS)

 

SILFAR® 1000 meets the criteria for an exemption from the requirements of a tolerance when used as an additive in pesticide formulations to be applied to growing crops or raw agricultural commodities after harvest as specified in 40 CR 180.960.

 

National regulations applicable in the countries concerned must be observed.

免责声明

所提供之所有信息均基于我们当前所掌握的知识。尽管如此,我们不对其作任何担保、也不承担任何责任,并且保留在任何时候进行技术变更的权利。购买方应在预测试中对所提供之信息以及产品在既定应用中的适应性进行检查。任何时候都必须以合同条款与条件为准。此外,本免责申明还适用于与第三方权利有关之事宜,尤其是在德国境外。

SILFAR® 1000 is used both in the pharmaceutical and food sectors. In the pharmaceutical sector it is used in antiflatulence and antacid preparations. It acts as an antifoam agent to prevent or relieve flatulence in the alimentary canal and forms a protective lining on e.g. the gastric mucous membrane.

 

SILFAR® 1000 may be used to make tablets and coated tablets. It is often combined with fermentation preparations.

 

SILFAR® 1000 is also used to control foam in fermentation and downstream processes, such as active-ingredient extraction and solvent recovery, especially when USP/EP compliant products are mandatory.

In the food sector, SILFAR® 1000 is used predominantly to control foam in lipophilic systems (foods rich in oil or fat, e.g. deep-frying oil) or for surface treatment. SILFAR® 1000 also serves as the base material in the production of antifoams compliant with the regulations pertaining to food for human consumption.

 

 

 

储存

The 'Best use before end' date of each batch is shown on the product label.

Storage beyond the date specified on the label does not necessarily mean that the product is no longer usable. In this case however, the properties required for the intended use must be checked for quality assurance reasons.

 

Additional information

 

Produced according ISO 9001, ISO 14001

销售和支持

Wacker Chemicals (China) Co.,Ltd.
Caohejing Hi-Tech Park
200233 Shanghai
中国
+86  21  6130-2000 (电话)
+86 21 6130-2500  (传真)
Contact Sales
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