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SILFAR® 100

1 of 9 products in this brand
SILFAR® 100 is a polydimethylsiloxane derived from the hydrolysis and polycondensation of dichlorodimethylsilane and chlorotrimethylsilane. Its degree of polymerization (n) is adjusted to achieve a mean kinematic viscosity of 100 mm²/s at 25°C. This product finds primary application in the pharmaceutical sector, particularly as a fundamental raw material in pharmaceutical formulations.

Chemical Name: Polydimethylsiloxane

CAS Number: 9006-65-9

Functions: Defoamer

Labeling Claims: Animal Products-free, BSE-free, TSE-free

Certifications & Compliance: BSE & TSE, BfR 14 Recommendation, BfR 15 Recommendation, BfR 36 Recommendation, BfR 36/2 Recommendation , BfR Recommendation, Coalition of Northeastern Governors (CONEG), Consumer Product Safety Improvement Act (CPSIA), Directive 2000/53/EC, Directive 2011/65/EC amended through EU/2015/863 (RoHS), EC No. 1935/2004, EU Packaging Directive (94/62/EC), European Pharmacopeia (Ph. Eur.), FDA 21 CFR 175.105, FDA 21 CFR 175.300, FDA 21 CFR 176.170, FDA 21 CFR 176.180, FDA 21 CFR 176.200, FDA 21 CFR 176.210, FDA 21 CFR 177.1200, FDA 21 CFR 177.1210, FDA 21 CFR 177.2260, FDA 21 CFR 177.2800, FDA 21 CFR 178.3120, GB 4806.1-2016, GB 9685-2016, ISO 14001, ISO 9001, National Formulary (NF), Regulation (EC) No. 1005/2009, Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1169/2011, Regulation (EU) No. 2019/1021, Swiss Ordinance (SR 817.023.21), United States Pharmacopeia (USP), Waste Electrical & Electronic Equipment Directive (WEEE), cGMP

Synonyms: Dimethicone

Technical Data Sheet

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Identification & Functionality

Chemical Name

Polydimethylsiloxane

Pharma & Nutraceuticals Functions

Defoamer

CAS No.
9006-65-9
EC No.
618-433-4
Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Formulation & Processing Aids

Chemical Structure

SILFAR® 100 - Chemical Structure

Features & Benefits

Labeling Claims

Animal Products-free,

BSE-free,

TSE-free

Applications & Uses

Applications

Pharma

Application Details

SILFAR® 100 is used predominantly in the pharmaceutical sector e.g. as an basic raw material in phamaceutical formulations.

Properties

Odor
Odorless
Typical Properties
ValueUnitsTest Method / Conditions
Aciditymax. 5mg/kgDirect Titration Method
Density (at 25°C)0.962 - 0.970 g/cm³DIN 51757
Kinematic Viscosity (at 25°C)95 - 105 mm²/sDIN 53018
Refractive Index (at 25°C)1.402 - 1.404——
Solidification Pointapprox. -55 °C—
Volatile Contentmax. 0.3 %USP
Properties

SILFAR® 100 complies with the requirements set down in the monographs Dimeticone (EP) and "Dimethicone" (USP / NF). Wacker explicitly rules out the use of SILFAR® 100 for parenteral applications.

Regulatory & Compliance

Certifications & Compliance

BSE & TSE,

BfR 14 Recommendation,

BfR 15 Recommendation,

BfR 36 Recommendation,

BfR 36/2 Recommendation ,

BfR Recommendation,

Coalition of Northeastern Governors (CONEG),

Consumer Product Safety Improvement Act (CPSIA),

Directive 2000/53/EC,

Directive 2011/65/EC amended through EU/2015/863 (RoHS),

EC No. 1935/2004,

EU Packaging Directive (94/62/EC),

European Pharmacopeia (Ph. Eur.),

FDA 21 CFR 175.105,

FDA 21 CFR 175.300,

FDA 21 CFR 176.170,

FDA 21 CFR 176.180,

FDA 21 CFR 176.200,

FDA 21 CFR 176.210,

FDA 21 CFR 177.1200,

FDA 21 CFR 177.1210,

FDA 21 CFR 177.2260,

FDA 21 CFR 177.2800,

FDA 21 CFR 178.3120,

GB 4806.1-2016,

GB 9685-2016,

ISO 14001,

ISO 9001,

National Formulary (NF),

Regulation (EC) No. 1005/2009,

Regulation (EU) No. 10/2011 (PIM),

Regulation (EU) No. 1169/2011,

Regulation (EU) No. 2019/1021,

Swiss Ordinance (SR 817.023.21),

United States Pharmacopeia (USP),

Waste Electrical & Electronic Equipment Directive (WEEE),

cGMP

Grade

Pharma Grade

Quality Standards

BS EN 71:2016 Safety of Toys Standard

Packaging & Availability

Country Availability

Afghanistan,

Albania,

Algeria,

American Samoa,

Andorra,

Angola,

Anguilla,

Antigua And Barbuda,

Argentina,

Armenia,

Aruba,

Australia,

Austria,

Azerbaijan,

Bahamas,

Bahrain,

Bangladesh,

Barbados,

Belarus,

Belgium,

Belize,

Benin,

Bermuda,

Bhutan,

Bolivia,

Bosnia and Herzegovina,

Botswana,

Bouvet Island,

Brazil,

British Indian Ocean Territory,

Brunei Darussalam,

Bulgaria,

Burkina Faso,

Burundi,

Cambodia,

Cameroon,

Canada,

Cape Verde,

Cayman Islands,

Central African Republic,

Chad,

Chile,

China (Mainland),

Christmas Island,

Cocos Islands,

Colombia,

Comoros,

Congo,

Cook Islands,

Costa Rica,

Cote D'Ivoire,

Croatia,

Cuba,

Cyprus,

Czech Republic,

Denmark,

Djibouti,

Dominica,

Dominican Republic,

Ecuador,

Egypt,

El Salvador,

Equatorial Guinea,

Eritrea,

Estonia,

Ethiopia,

Falkland Islands,

Faroe Islands,

Fiji,

Finland,

France,

French Guiana,

French Polynesia,

Gabon,

Gambia,

Georgia,

Germany,

Ghana,

Gibraltar,

Greece,

Greenland,

Grenada,

Guadeloupe,

Guam,

Guatemala,

Guinea,

Guinea-Bissau,

Guyana,

Haiti,

Heard Island and McDonald Islands,

Honduras,

Hong Kong,

Hungary,

Iceland,

India,

Indonesia,

Iran,

Iraq,

Ireland,

Israel,

Italy,

Jamaica,

Japan,

Jordan,

Kazakhstan,

Kenya,

Kiribati,

Korea,

Kuwait,

Kyrgyzstan,

Laos,

Latvia,

Lebanon,

Lesotho,

Liberia,

Libyan Arab Jamahiriya,

Liechtenstein,

Lithuania,

Luxembourg,

Macao,

Macedonia,

Madagascar,

Malawi,

Malaysia,

Maldives,

Mali,

Malta,

Marshall Islands,

Martinique,

Mauritania,

Mauritius,

Mayotte,

Mexico,

Micronesia,

Moldova,

Monaco,

Mongolia,

Montenegro,

Montserrat,

Morocco,

Mozambique,

Myanmar,

Namibia,

Nauru,

Nepal,

Netherlands,

Netherlands Antilles,

New Caledonia,

New Zealand,

Nicaragua,

Niger,

Nigeria,

Niue,

Norfolk Island,

North Corea,

Northern Mariana Islands,

Norway,

Oman,

Pakistan,

Palau,

Palestinian Territory,

Panama,

Papua New Guinea,

Paraguay,

Peru,

Philippines,

Pitcairn,

Poland,

Portugal,

Puerto Rico,

Qatar,

Reunion,

Romania,

Russia,

Rwanda,

Saint Helena,

Saint Kitts and Nevis,

Saint Lucia,

Saint Pierre And Miquelon,

Saint Vincent And The Grenadines,

Samoa,

San Marino,

Sao Tome and Principe,

Saudi Arabia,

Senegal,

Serbia,

Seychelles,

Sierra Leone,

Singapore,

Slovakia,

Slovenia,

Solomon Islands,

Somalia,

South Africa,

Spain,

Sri Lanka,

Sudan,

Suriname,

Svalbard And Jan Mayen,

Swaziland,

Sweden,

Switzerland,

Syrian Arab Republic,

Taiwan,

Tajikistan,

Tanzania,

Thailand,

Togo,

Tokelau,

Tonga,

Trinidad And Tobago,

Tunisia,

Turkey,

Turkmenistan,

Turks And Caicos Islands,

Tuvalu,

USA,

Uganda,

Ukraine,

United Arab Emirates,

United Kingdom,

United States Minor Outlying Islands,

Uruguay,

Uzbekistan,

Vanuatu,

Vatican City,

Venezuela,

Vietnam,

Virgin Islands, British,

Virgin Islands, U.S.,

Wallis And Futuna,

Western Sahara,

Yemen,

Zambia,

Zimbabwe

Regional Availability
  • Africa
  • Asia
  • Europe
  • Latin America
  • Middle East
  • North America
  • Oceania

Storage & Handling

Shelf Life
720 Days
Storage Information

Keep container tightly closed. Store container(s) at room temperature in a dry, wellventilated place.