Simethicone (CAS 8050-81-5) — formula C6H18O4Si3, molecular weight 238.46; category pharmaceutical intermediates and APIs.
| CAS Number | 8050-81-5 |
|---|---|
| Molecular Formula | C6H18O4Si3 |
| Molecular Weight | 238.46 |
| Applications | Uses: The main use of simethicone as an excipient is as an antifoaming agent in pharmaceutical manufacturing processes ... ., A poly(dimethylsiloxane) which is a polymer of 200-350 units of dimethylsiloxane, along with added silica gel. It is used as an antiflatulent, surfactant, and ointment base., Antifoaming ingredient in cosmetics, Simethicone manufactured under the name of MED-340 is used in the production of anti-gas tablets, lubrication and bubble free application of topical preparations, anti-whitening properties in acne and other dermatological ointments, creams and lotions, as an antifoam in the manufacture of drug products made by microbial fermentations, listed in the INCI index for use in cosmetic and toiletry products., For more Uses (Complete) data for Simethicone (6 total), please visit the HSDB record page., Use Classification: Food Additives -> ANTICAKING_AGENT, ANTIFOAMING_AGENT -> JECFA Functional Classes, Food Additives -> ANTICAKING_AGENT, Cosmetics -> Skin conditioning, Emollient, Hair conditioning, Antifoaming, Industry Uses: Defoamer, Household Products: Information on 107 consumer products that contain Simethicone in the following categories is provided:, • Inside the Home, • Personal Care, Methods of Manufacturing: Silicone 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., Formulations, Preparations: Antifoam A, Baros, Colicon, Endo-Paractol, Gas-X, Infacol, Lefax, Mylicon, Phasil, Phazyne, sab simplex, Silain., Table: Simethicone Combinations [Table#4658], Table: Simethicone Preparations [Table#4659], Simethicone is a mixture of fully methylated linear siloxane polymers containing repeating units of polydimethylsiloxane, stabilized with trimethylsiloxy end-blocking units, and silicon dioxide. Simethicone contains 90.5-99% of polydimethylsiloxane and 4-7% silicon dioxide., U.S. Production: 2023: <50, 000 lb, 2022: <50, 2021: <50, 2020: <50, General Manufacturing Information: Not Known or Reasonably Ascertainable, Dimethecone mixed with silicon dioxide is known as simethicone, The defoaming power of simethicone, when assoc with antacid, is more pronounced in suspension than in tablets. Incorporation of lactose in tablets enhances the defoaming efficiency. Antiflatulent-antispasmodic digestive tablets (simethicone, belladonna ext, pepsin, pancreatin, and dehydrocholic acid) achieve a mild decrease in their defoaming efficiency when stored for 360 days at 25 °C. Pepsin shows a reduction in its activity in tablets with simethicone while pancreatin achieves relatively greater stability with simethicone. The stability of total alkaloid content of belladonna is also improved with simethicone., Average number of dimethylsiloxane units is 200 to 350., NuSil currently manufactures a simethicone product line consisting of the MED-340 Simethicone USP (100%), MED-341 Simethicone Emulsion USP (30%), and the MED-342 Simethicone GS (30% granular solid). The MED-340 and MED-341 are USP monographed products while the MED-342 is a mixture of simethicone USP and a maltodextrin substrate. |
| Category | Pharma Excipients |
Documented applications: Uses: The main use of simethicone as an excipient is as an antifoaming agent in pharmaceutical manufacturing processes ... ., A poly(dimethylsiloxane) which is a polymer of 200-350 units of dimethylsiloxane, along with added silica gel. It is used as an antiflatulent, surfactant, and ointment base., Antifoaming ingredient in cosmetics, Simethicone manufactured under the name of MED-340 is used in the production of anti-gas tablets, lubrication and bubble free application of topical preparations, anti-whitening properties in acne and other dermatological ointments, creams and lotions, as an antifoam in the manufacture of drug products made by microbial fermentations, listed in the INCI index for use in cosmetic and toiletry products., For more Uses (Complete) data for Simethicone (6 total), please visit the HSDB record page., Use Classification: Food Additives -> ANTICAKING_AGENT, ANTIFOAMING_AGENT -> JECFA Functional Classes, Food Additives -> ANTICAKING_AGENT, Cosmetics -> Skin conditioning, Emollient, Hair conditioning, Antifoaming, Industry Uses: Defoamer, Household Products: Information on 107 consumer products that contain Simethicone in the following categories is provided:, • Inside the Home, • Personal Care, Methods of Manufacturing: Silicone 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., Formulations, Preparations: Antifoam A, Baros, Colicon, Endo-Paractol, Gas-X, Infacol, Lefax, Mylicon, Phasil, Phazyne, sab simplex, Silain., Table: Simethicone Combinations [Table#4658], Table: Simethicone Preparations [Table#4659], Simethicone is a mixture of fully methylated linear siloxane polymers containing repeating units of polydimethylsiloxane, stabilized with trimethylsiloxy end-blocking units, and silicon dioxide. Simethicone contains 90.5-99% of polydimethylsiloxane and 4-7% silicon dioxide., U.S. Production: 2023: <50, 000 lb, 2022: <50, 2021: <50, 2020: <50, General Manufacturing Information: Not Known or Reasonably Ascertainable, Dimethecone mixed with silicon dioxide is known as simethicone, The defoaming power of simethicone, when assoc with antacid, is more pronounced in suspension than in tablets. Incorporation of lactose in tablets enhances the defoaming efficiency. Antiflatulent-antispasmodic digestive tablets (simethicone, belladonna ext, pepsin, pancreatin, and dehydrocholic acid) achieve a mild decrease in their defoaming efficiency when stored for 360 days at 25 °C. Pepsin shows a reduction in its activity in tablets with simethicone while pancreatin achieves relatively greater stability with simethicone. The stability of total alkaloid content of belladonna is also improved with simethicone., Average number of dimethylsiloxane units is 200 to 350., NuSil currently manufactures a simethicone product line consisting of the MED-340 Simethicone USP (100%), MED-341 Simethicone Emulsion USP (30%), and the MED-342 Simethicone GS (30% granular solid). The MED-340 and MED-341 are USP monographed products while the MED-342 is a mixture of simethicone USP and a maltodextrin substrate..
Simethicone is a pharmaceutical intermediate or API compound with CAS registry number 8050-81-5 and molecular formula C6H18O4Si3 (molecular weight 238.46), belonging to the pharmaceutical intermediates and APIs segment of chemical raw materials.
CAS number: 8050-81-5
Its molecular formula C6H18O4Si3 comprises 6 C, 18 H, 4 O, 3 Si atoms.
Also known as: Simethicone · 西甲硅油 · POLYDIMETHYLSILOXANE
Category: pharmaceutical intermediates and APIs
The CAS registry number of Simethicone is 8050-81-5.
Molecular formula C6H18O4Si3, molecular weight 238.46.
It is also registered under: Simethicone, 西甲硅油, POLYDIMETHYLSILOXANE.
Recorded applications: Uses: The main use of simethicone as an excipient is as an antifoaming agent in pharmaceutical manufacturing processes ... ., A poly(dimethylsiloxane) which is a polymer of 200-350 units of dimethylsiloxane, along with added silica gel. It is used as an antiflatulent, surfactant, and ointment base., Antifoaming ingredient in cosmetics, Simethicone manufactured under the name of MED-340 is used in the production of anti-gas tablets, lubrication and bubble free application of topical preparations, anti-whitening properties in acne and other dermatological ointments, creams and lotions, as an antifoam in the manufacture of drug products made by microbial fermentations, listed in the INCI index for use in cosmetic and toiletry products., For more Uses (Complete) data for Simethicone (6 total), please visit the HSDB record page., Use Classification: Food Additives -> ANTICAKING_AGENT, ANTIFOAMING_AGENT -> JECFA Functional Classes, Food Additives -> ANTICAKING_AGENT, Cosmetics -> Skin conditioning, Emollient, Hair conditioning, Antifoaming, Industry Uses: Defoamer, Household Products: Information on 107 consumer products that contain Simethicone in the following categories is provided:, • Inside the Home, • Personal Care, Methods of Manufacturing: Silicone 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., Formulations, Preparations: Antifoam A, Baros, Colicon, Endo-Paractol, Gas-X, Infacol, Lefax, Mylicon, Phasil, Phazyne, sab simplex, Silain., Table: Simethicone Combinations [Table#4658], Table: Simethicone Preparations [Table#4659], Simethicone is a mixture of fully methylated linear siloxane polymers containing repeating units of polydimethylsiloxane, stabilized with trimethylsiloxy end-blocking units, and silicon dioxide. Simethicone contains 90.5-99% of polydimethylsiloxane and 4-7% silicon dioxide., U.S. Production: 2023: <50, 000 lb, 2022: <50, 2021: <50, 2020: <50, General Manufacturing Information: Not Known or Reasonably Ascertainable, Dimethecone mixed with silicon dioxide is known as simethicone, The defoaming power of simethicone, when assoc with antacid, is more pronounced in suspension than in tablets. Incorporation of lactose in tablets enhances the defoaming efficiency. Antiflatulent-antispasmodic digestive tablets (simethicone, belladonna ext, pepsin, pancreatin, and dehydrocholic acid) achieve a mild decrease in their defoaming efficiency when stored for 360 days at 25 °C. Pepsin shows a reduction in its activity in tablets with simethicone while pancreatin achieves relatively greater stability with simethicone. The stability of total alkaloid content of belladonna is also improved with simethicone., Average number of dimethylsiloxane units is 200 to 350., NuSil currently manufactures a simethicone product line consisting of the MED-340 Simethicone USP (100%), MED-341 Simethicone Emulsion USP (30%), and the MED-342 Simethicone GS (30% granular solid). The MED-340 and MED-341 are USP monographed products while the MED-342 is a mixture of simethicone USP and a maltodextrin substrate..
Category: Pharma Excipients.
Independent reference data for Simethicone (CAS 8050-81-5), compiled from public chemistry databases.
| CAS Registry Number | 8050-81-5 |
|---|---|
| PubChem CID | 6433516 |
| Molecular formula | C6H18O4Si3 |
| IUPAC name | dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane |
| UNII (FDA) | SIMETICONE |
| Molecular Weight | 238.46 |
|---|---|
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 3 |
| Exact Mass | 238.05128865 |
| Monoisotopic Mass | 238.05128865 |
| Topological Polar Surface Area | 52.6 |
| Heavy Atom Count | 13 |
Simethicone; 8050-81-5; Sentry Simethicone; Mylanta Gas Relief; Mylicon Infant's Drops; Sentry Simethicone Emulsion; DTXSID00904918; RefChem:886342; 3,3,5,5-tetramethyl-2,4-dioxa-3,5-disilahexane; silanedione; 617-098-1; dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane; Simethicon; Simethicone(200); Simethicone(500); SIMETICONE; C6H18O4Si3
| Regulatory & Food Contact | ANTICAKING_AGENT; ANTIFOAMING_AGENT: Food Additives DIMETHYLPOLYSILOXANE 0â1.5 mg/kg bw The Committee withdrew the temporary ADI of 0â0.8 mg/kg body weight per day and re-established the ADI of 0â TRS 966-JECFA 74/27 FAS 60-JECFA 69/165 |
|---|---|
| GHS notification summary | 96.6% (86 / 89) |
| GHS notification summary | 96.6% (86 / 89) |
|---|---|
| Reported hazard statements | H225 (100%), H319 (100%), H335 (100%), H336 (100%) |
This chemical does not meet GHS hazard criteria for 96.6% (86 of 89) of all reports.
Reported as not meeting GHS hazard criteria by 86 of 89 companies (only 3.4% companies provided GHS information). For more detailed information, please visit ECHA C&L website.
POLYDIMETHYLSILOXANE · CAS 8050-81-5 · C6H18O4Si3. UNII SIMETICONE.
Source: PubChem / Wikidata; the batch COA governs where values differ.
Supplier: Jinan Shenghe Chemical Co., Ltd.
中文页面: 聚二甲基硅氧烷