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SILFAR® 100

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.

Brand: SILFAR (9 products)

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

Enhanced TDS

Knowde-enriched technical product data sheet

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

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


	Value	Units	Test Method / Conditions
Acidity	max. 5	mg/kg	Direct Titration Method
Density (at 25°C)	0.962 - 0.970	g/cm³	DIN 51757
Kinematic Viscosity (at 25°C)	95 - 105	mm²/s	DIN 53018
Refractive Index (at 25°C)	1.402 - 1.404	-	-
Solidification Point	approx. -55	°C	-
Volatile Content	max. 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

American Samoa,

Antigua And Barbuda,

Bosnia and Herzegovina,

British Indian Ocean Territory,

Brunei Darussalam,

Cayman Islands,

Central African Republic,

China (Mainland),

Christmas Island,

Czech Republic,

Dominican Republic,

Equatorial Guinea,

Falkland Islands,

French Polynesia,

Heard Island and McDonald Islands,

Libyan Arab Jamahiriya,

Marshall Islands,

Netherlands Antilles,

Norfolk Island,

Northern Mariana Islands,

Palestinian Territory,

Papua New Guinea,

Saint Kitts and Nevis,

Saint Pierre And Miquelon,

Saint Vincent And The Grenadines,

Sao Tome and Principe,

Solomon Islands,

Svalbard And Jan Mayen,

Syrian Arab Republic,

Trinidad And Tobago,

Turks And Caicos Islands,

United Arab Emirates,

United Kingdom,

United States Minor Outlying Islands,

Virgin Islands, British,

Virgin Islands, U.S.,

Wallis And Futuna,

Western Sahara,

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.