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PRODUCT DETAILS
POLYDIMETHYLSILOXANE Basic information |
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POLYDIMETHYLSILOXANE Chemical Properties |
density |
1 g/mL at 20 °C |
vapor pressure |
5 mm Hg ( 20 °C) |
refractive index |
n20/D 1.406 |
Fp |
>101°C |
storage temp. |
room temp |
solubility |
Practically insoluble in water, very slightly soluble or practically insoluble in anhydrous ethanol, practically insoluble in methanol, partly miscible with ethyl acetate, with methylene chloride, with methyl ethyl ketone and with toluene. |
form |
emulsion |
color |
Colorless |
EPA Substance Registry System |
Simethicone (8050-81-5) |
Provider |
Language |
SigmaAldrich |
English |
ACROS |
English |
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POLYDIMETHYLSILOXANE Usage And Synthesis |
Chemical Properties |
Viscous, greyish-white, opalescent liquid. |
Chemical Properties |
The PhEur 6.0 and USP 32 describe simethicone as a mixture of fully methylated linear siloxane polymers containing repeating units of the formula [–(CH3)2SiO–]n, stabilized with trimethylsiloxy endblocking units of the formula [(CH3)3 SiO–], and silicon dioxide. It contains not less than 90.5% and not more than 99.0% of the polydimethylsiloxane [–(CH3)2SiO–]n, and not less than 4.0% and not more than 7.0% of silicon dioxide. The PhEur 6.0 additionally states that the degree of polymerization is between 20–400.
Simethicone occurs as a translucent, gray-colored, viscous fluid. It has a molecular weight of 14 000–21 000. |
Originator |
Mylicon,Stuart,U.S.,1960 |
Uses |
Antifoam A Concentrate has been used as a component of Luria Bertani culture medium for growth of BL21 (DE3) E. coli cells transformed with the plasmids. It has also been used as a constituent in the preparation of aerosol generation fluid.
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Uses |
Simethicone is an oral anti-foaming agent used to reduce bloating, discomfort and pain caused by excess gas in the stomach or intestinal tract. Simethicone is a mixture of polydimethylsiloxane and hydrated silica gel. |
Uses |
Simethicone Emulsion USP is a water dilutable, non-ionic emulsion containing 30% Simethicone USP by weight. Highly stable over a broad pH range. Simethicones are used as anti foam agents in the manufacture of drugs. Their use in Pharmaceuticals is to comb |
Production Methods |
Silicon dioxide is initially rendered hydrophobic in one of a variety of proprietary processes specific to a particular manufacturer. It is then slowly mixed with the silicone fluids in a formulation. After mixing, the simethicone is milled to ensure uniformity. |
Manufacturing Process |
In a 5 liter three-necked flask, fitted with a reflux condenser, agitator and thermometer, were placed 1,393 g (9.41 mold) of redistilled (CH3)2Si(OEt)2 and 1,110 g (9.41 mols) of (CH3)3SiOEt. To this solution was added 254 g (14.11 mols) of water containing 7.5 g of NaOH (approximately 1 NaOH per 100 silicon atoms). This insured the formation of only straight chain polymers. The mixture was heated to 40°C and the temperature continued to rise for nearly an hour. After adding 50 cc (20% excess) more water, the mixture was refluxed for two hours and then allowed to stand overnight.
Alcohol was then distilled off, until the temperature reached 100°C. 1,706.6 g of distillate was collected. (Theory 1,430 g.) This alcohol was poured into four times its volume of water and an insoluble oil separated (457 g). The insoluble fraction was added back to the copolymer residue from the distillation and 555 cc of 20% hydrochloric acid was added. The acid mixture was refluxed for two hours, and the silicon oils were carefully washed with distilled water until neutral. The yield was 1,420 g. (Theory 1,409 g.) |
Brand name |
Gas-X (Novartis); Mylanta Gas Relief (Johnson & Johnson-Merck Consumer); Mylicon Infant’s Drops (Johnson & Johnson-Merck Consumer); Sentry Simethicone (Witco); Sentry Simethicone Emulsion (Witco). |
Therapeutic Function |
Antiflatulent |
General Description |
Antifoam A Concentrate is an extremely effective foam suppressor for aqueous and non-aqueous systems. It is 100% active silicone polymer. No emulsifiers are present. Antifoam A Concentrate is typically effective at 1-100 ppm. Antifoam A Concentrate should be diluted with 3-10 parts of propylene glycol (aqueous) or vegetable oil (nonaqueous) with slow mixing. The product will be stable in the pH range of 5 to 9. Antifoam A Concentrate can be added directly to a fermentation medium, but it is not recommended that it be pumped to a fermenter on an as-needed basis.
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Pharmaceutical Applications |
The main use of simethicone as an excipient is as an antifoaming agent in pharmaceutical manufacturing processes, for which 1–50 ppm is used.
Therapeutically, simethicone is included in a number of oral pharmaceutical formulations as an antiflatulent, although its therapeutic benefit is questionable. It is also included in antacid products such as tablets or capsules. In some types of surgical or gastroscopic procedures where gas is used to inflate the body cavity, a defoaming preparation containing simethicone may be used in the area to control foaming of the fluids.
When simethicone is used in aqueous formulations, it should be emulsified to ensure compatibility with the aqueous system and components.
In the USA, up to 10 ppm of simethicone may be used in food products. |
Safety |
Simethicone is used in cosmetics, foods, and oral and topical pharmaceutical formulations, and is generally regarded as a relatively nontoxic and nonirritant material when used as an excipient. Direct contact with the eye may cause irritation.
Therapeutically, oral doses of 125–250mg of simethicone, three or four times daily, have been given as an antiflatulent. Doses of 20–40 mg of simethicone have been given with feeds to relieve colic in infants.
LD50 (dog, IV): 0.9 g/kg |
storage |
Simethicone is generally regarded as a stable material when stored in the original unopened container. A shelf-life of 18 months from the date of manufacture is typical. However, some simethicone products have a tendency for the silicon dioxide to settle slightly and containers of simethicone should therefore be shaken thoroughly to ensure uniformity of contents before sampling or use. Simethicone should be stored in a cool, dry, location away from oxidizing materials.
Simethicone can be sterilized by dry heating or autoclaving. With dry heating, a minimum of 4 hours at 160℃ is required. |
Incompatibilities |
Simethicone as supplied is not generally compatible with aqueous systems and will float like an oil on a formulation unless it is first emulsified. It should not be used in formulations or processing conditions that are very acidic (below pH 3) or highly alkaline (above pH 10), since these conditions may have some tendency to break the polydimethylsiloxane polymer. Simethicone cannot normally be mixed with polar solvents of any kind because it is very minimally soluble. Simethicone is incompatible with oxidizing agents. |
Regulatory Status |
GRAS listed. Included in the FDA Inactive Ingredients Database (oral emulsions, powders, solutions, suspensions, tablets; and rectal and topical preparations). Included in nonparenteral medicines licensed in the UK. |
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POLYDIMETHYLSILOXANE Preparation Products And Raw materials |
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About US
Leader Biochemical Group is a large leader incorporated industry manufacturers and suppliers of advanced refined raw materials From the year of 1996 when our factory was put into production to year of 2020, our group has successively invested in more than 52 factories with shares and subordinates.We focus on manufacture Pharm & chemicals, functional active ingredients, nutritional Ingredients, health care products, cosmetics, pharmaceutical and refined feed, oil, natural plant ingredients industries to provide top quality of GMP standards products.All the invested factories' product lines cover API and intermediates, vitamins, amino acids, plant extracts, daily chemical products, cosmetics raw materials, nutrition and health care products, food additives, feed additives, essential oil products, fine chemical products and agricultural chemical raw materials And flavors and fragrances. Especially in the field of vitamins, amino acids, pharmaceutical raw materials and cosmetic raw materials, we have more than 20 years of production and sales experience. All products meet the requirements of high international export standards and have been recognized by customers all over the world. Our manufacture basement & R&D center located in National Aerospace Economic & Technical Development Zone Xi`an Shaanxi China. Now not only relying on self-cultivation and development as well as maintains good cooperative relations with many famous research institutes and universities in China. Now, we have closely cooperation with Shanghai Institute of Organic Chemistry of Chinese Academy of Science, Beijing Institute of Material Medical of Chinese Academy of Medical Science, China Pharmaceutical University, Zhejiang University. Closely cooperation with them not only integrating Science and technology resources, but also increasing the R&D speed and improving our R&D power. Offering Powerful Tech supporting Platform for group development. Keep serve the manufacture and the market as the R&D central task, focus on the technical research. Now there are 3 technology R & D platforms including biological extract, microorganism fermentation and chemical synthesis, and can independently research and develop kinds of difficult APIs and pharmaceutical intermediates. With the strong support of China State Institute of Pharmaceutical Industry (hereinafter short for CSIPI), earlier known as Shanghai Institute of Pharmaceutical Industry (SIPI), we have unique advantages in the R & D and industrialization of high-grade, precision and advanced products. Now our Group technical force is abundant, existing staff more that 1000 people, senior professional and technical staff accounted for more than 50% of the total number of employees, including 15 PhD research and development personnel, 5 master′ S degree in technical and management personnel 9 people. We have advanced equipment like fermentation equipment and technology also extraction, isolation, purification, synthesis with rich production experience and strict quality control system, According to the GMP required, quickly transforming the R&D results to industrial production in time, it is our advantages and our products are exported to North and South America, Europe, Middle East, Africa, and other five continents and scale the forefront in the nation, won good international reputation. We believe only good quality can bring good cooperation, quality is our key spirit during our production, we are warmly welcome clients and partner from all over the world contact us for everlasting cooperation, Leader will be your strong, sincere and reliable partner in China.
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