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Chemistry

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Also known as: 107-51-7, Trisiloxane, octamethyl-, Poly(dimethylsiloxane), 1,1,1,3,3,5,5,5-octamethyltrisiloxane, Dimeticone, Dimethyl-bis(trimethylsilyloxy)silane
Molecular Formula
C8H24O2Si3
Molecular Weight
236.53  g/mol
InChI Key
CXQXSVUQTKDNFP-UHFFFAOYSA-N
FDA UNII
9G1ZW13R0G

Dimethicone
1 2D Structure

Dimethicone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
dimethyl-bis(trimethylsilyloxy)silane
2.1.2 InChI
InChI=1S/C8H24O2Si3/c1-11(2,3)9-13(7,8)10-12(4,5)6/h1-8H3
2.1.3 InChI Key
CXQXSVUQTKDNFP-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C[Si](C)(C)O[Si](C)(C)O[Si](C)(C)C
2.2 Other Identifiers
2.2.1 UNII
9G1ZW13R0G
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Baysilon

2. Macroplastique

3. Poly(dimethylsiloxane)

4. Polydimethylsiloxane

5. Rtv S-5392

6. Silastic

7. Siliconique

8. Silikon 1000

9. Simpa

2.3.2 Depositor-Supplied Synonyms

1. 107-51-7

2. Trisiloxane, Octamethyl-

3. Poly(dimethylsiloxane)

4. 1,1,1,3,3,5,5,5-octamethyltrisiloxane

5. Dimeticone

6. Dimethyl-bis(trimethylsilyloxy)silane

7. Dimethicone 350

8. 63148-62-9

9. Pentamethyl(trimethylsilyloxy)disiloxane

10. Dimethylbis(trimethylsiloxy)silane

11. 9g1zw13r0g

12. Chebi:9147

13. Trisiloxane, 1,1,1,3,3,5,5,5-octamethyl-

14. Dimethylbis(trimethylsilyloxy)silane

15. Dimethicones

16. Poly(dimethylsiloxane), Hydroxy Terminated

17. Mfcd00084411

18. Mfcd00134211

19. Mfcd00148360

20. Ccris 3198

21. Poly(dimethylsiloxane), Trimethylsiloxy Terminated

22. Einecs 203-497-4

23. Dimeticonum

24. Unii-9g1zw13r0g

25. Dimeticona

26. Frd 20

27. Ctamethyltrisiloxane

28. Mfcd00008264

29. Pentamethyl(trimethylsiloxy)disiloxane

30. Octamethyl-trisiloxane

31. Pdms

32. Dimethicone Macromolecule

33. Volasil Dm-1

34. Silicon Oil For Oil Bath

35. Trisiloxane [inci]

36. Dm-fluid 1.0cs

37. Ec 203-497-4

38. Octamethyltrisiloxane, 98%

39. Dsstox_cid_20710

40. Dsstox_rid_79558

41. Dsstox_gsid_40710

42. Os 20 (siloxane)

43. Schembl23459

44. Siliconoil Pharma 100 Cst.

45. Dimethyl Polysiloxane, Bis(trimethylsilyl)-terminated

46. Dow Corning High-vacuum Grease

47. Chembl2142985

48. Dtxsid9040710

49. Chebi:31498

50. Cxqxsvuqtkdnfp-uhfffaoysa-

51. Kf 96a1

52. Octamethyltrisiloxane [mi]

53. Dimethylbis(trimethylsiloxy)siliane

54. Polydimethylsiloxane, 1000 Cst.

55. Alpha-(trimethylsilyl)-omega-methylpoly(oxy(dimethylsilylene))

56. [(ch3)3sio]2si(ch3)2

57. Tox21_301002

58. Co9816

59. Mfcd00165850

60. Silane, Dimethylbis(trimethylsiloxy)-

61. Akos015840180

62. Zinc169747808

63. Antifoam Compound For Anhydrous Systems

64. Fs-4459

65. Ncgc00164100-01

66. Ncgc00164100-02

67. Ncgc00254904-01

68. Cas-107-51-7

69. Db-040764

70. Ft-0631598

71. Ft-0696355

72. O0257

73. O9816

74. C07261

75. D91850

76. S12475

77. A801717

78. Xiameter(r) Pmx-200 Silicone Fluid 1 Cst

79. J-001906

80. Poly(dimethylsiloxane), Viscosity 1.0 Cst (25 C)

81. Q2013799

82. Xiameter(r) Pmx-200 Silicone Fluid 20 Cs

83. 2,2,4,4,6,6-hexamethyl-3,5-dioxa-2,4,6-trisilaheptane

84. Polydimethylsiloxane, 20,000 Cst. Trimethoxysilyl Terminated

85. Polydimethylsiloxane, Extreme Low Volatility, Viscosity 1000 Cst.

86. Intermediate Viscosity Polydimethylsiloxane Antifoam Emulsion, 20% Active, Viscosity 1500cst

87. Intermediate Viscosity Polydimethylsiloxane Antifoam Emulsion, 30% Active, Viscosity 1500cst

88. Polydimethylsiloxane, Trimethylsiloxy Terminated, Reduced Volatility, Viscosity 20 Cst.

89. 28349-86-2

90. Intermediate Viscosity Polydimethylsiloxane Antifoam Emulsion, 10% Active, Viscosity 1000-2000cst

91. Intermediate Viscosity Polydimethylsiloxane Antifoam Emulsion, 10% Active, Viscosity 800-2000cst

92. Intermediate Viscosity Polydimethylsiloxane Antifoam Emulsion, 20% Active, Viscosity 1000-2000cst

93. Intermediate Viscosity Polydimethylsiloxane Antifoam Emulsion, 30% Active, Viscosity 1000-2000cst

94. Polydimethylsiloxane, Trimethylsiloxy Terminated, Extreme Low Volatility, Viscosity 12.500 Cst.

2.4 Create Date
2005-03-27
3 Chemical and Physical Properties
Molecular Weight 236.53 g/mol
Molecular Formula C8H24O2Si3
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count2
Rotatable Bond Count4
Exact Mass236.10840961 g/mol
Monoisotopic Mass236.10840961 g/mol
Topological Polar Surface Area18.5 Ų
Heavy Atom Count13
Formal Charge0
Complexity149
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 FDA Pharmacological Classification
4.1.1 Pharmacological Classes
Skin Barrier Activity [PE]
4.2 ATC Code

P - Antiparasitic products, insecticides and repellents

P03 - Ectoparasiticides, incl. scabicides, insecticides and repellents

P03A - Ectoparasiticides, incl. scabicides

P03AX - Other ectoparasiticides, incl. scabicides

P03AX05 - Dimeticone


API SUPPLIERS

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USDMF

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01

Riocare India Pvt Ltd

India

USDMF

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18688

Submission : 2005-08-05

Status : Active

Type : II

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Cophex
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02

03

Dow Corning Corp

U.S.A

USDMF

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NDC API

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DIMETHICONE

NDC Package Code : 13924-342

Start Marketing Date : 2007-01-25

End Marketing Date : 2025-11-15

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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DIMETHICONE

NDC Package Code : 44331-5001

Start Marketing Date : 2017-10-09

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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DIMETHICONE; SILICON DIOXIDE; TITANIUM DIOXIDE

NDC Package Code : 63238-2750

Start Marketing Date : 2021-09-30

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (.03kg/kg .125kg/kg .845kg/kg)

Marketing Category : DRUG FOR FURTHER PROCESSING

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API Reference Price

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MAHARASHTRA.","supplier":"CRODA INTERNATIONAL PLC","supplierCountry":"UNITED STATES","foreign_port":"NEWARK, NJ","customer":"CRODA INTERNATIONAL PLC","customerCountry":"INDIA","quantity":"18.00","actualQuantity":"18","unit":"KGS","unitRateFc":"47.5","totalValueFC":"865.4","currency":"USD","unitRateINR":"4007.5","date":"11-May-2024","totalValueINR":"72134.43","totalValueInUsd":"865.4","indian_port":"Bombay Air","hs_no":"29232090","bill_no":"3440125","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEWARK, NJ","supplierAddress":"777 SCUDDERS MILL ROAD, BLDG. 2 SUITE 200 PLAINSBORO, NJ 08536 New JERSEY, , UNITED STATES UNITED STATES","customerAddress":"PLOT NO 1\/1 PART TTC INDL AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718649000,"product":"ARLASILK PLN-LQ-(AP) (WATER (AND)LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE DIMETHICONE)","address":"PLOT NO 1\/1 PART TTC INDL AREA","city":"NAVI MUMBAI. 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K","supplierAddress":"777 SCUDDERS MILL ROAD, BLDG. 2 SUITE 200 PLAINSBORO, NJ 08536 New JERSEY, , UNITED STATES UNITED STATES","customerAddress":"PLOT NO 1\/1 PART TTC INDL AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725906600,"product":"24503 BRB DM 2 (DIMETHICONE) (RAW MATERIAL FOR COSMETICS USE)","address":"GROUND FLOOR, CORPORATE ONE","city":"DELHI","supplier":"BRB INTERNATIONAL B.V.","supplierCountry":"NETHERLANDS","foreign_port":"ROTTERDAM","customer":"ORIFLAME INDIA PRIVATE ","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"21.4","totalValueFC":"1002.9","currency":"EUR","unitRateINR":"2101.1","date":"10-Sep-2024","totalValueINR":"84044.8","totalValueInUsd":"1002.9","indian_port":"Delhi PPG ICD","hs_no":"29319090","bill_no":"5515934","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"PO BOX 3552 NL-6017 ZH THORN, OFFIC E EUROPASTRAAT 5, NL-6014 CD ITTERV OORT ., , NETHERLANDS NETHERLANDS NETHERLANDS","customerAddress":"GROUND FLOOR, CORPORATE ONE"}]
12-Jul-2021
25-Feb-2025
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Excipients by Applications

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Topical

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01

Evonik

Germany
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEvonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Grade : Topical

Category : Topical

Brand Name : L-Lysine HCl

Excipient Details : L-Lysine HCl is used in semi-solid dosage forms such as creams, lotions, shampoos, etc.

Pharmacopoeia Ref : NA

Technical Specs : Molecular weight: 182.7 g/mol

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02

EUROAPI

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

Grade : Topical, Parenteral

Category : Parenteral, Topical

04

DKSH

Switzerland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Grade : Topical, Parenteral

Category : Solubilizers, Topical

05

DKSH

Switzerland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Grade : Topical

Category : Topical

Brand Name : Aquapol® SF-1

Excipient Details : Aquapol® SF-1 is used in gel based ointments, solutions and other topical dosage forms.

Pharmacopoeia Ref : N/A

Technical Specs : N/A

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06

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Cophex
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Topical

Category : Topical

Brand Name : Inositol

Excipient Details : Inositol is used in topical dosage forms such as creams, lotions and ointments.

Pharmacopoeia Ref : NA

Technical Specs : NA

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07

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Cophex
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Topical

Category : Topical

08

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Cophex
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Topical

Category : Topical

09

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Cophex
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

10

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Cophex
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

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Fillers, Diluents & Binders

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01

EUROAPI

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

Grade : Oral

Category : Fillers, Diluents & Binders

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Grade : Oral

Category : Fillers, Diluents & Binders, Taste Masking

05

SPI Pharma

U.S.A
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World Vaccine Conference
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

06

SPI Pharma

U.S.A
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World Vaccine Conference
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

07

08

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MAGHREB PHARMA
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Oral

Category : Co-Processed Excipients

09

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MAGHREB PHARMA
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Oral

Category : Fillers, Diluents & Binders

10

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MAGHREB PHARMA
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Grade : Oral (Pharma Grade)

Category : Fillers, Diluents & Binders

Brand Name : KoVidone® K25

Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.

Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

Technical Specs : NA

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Thickeners and Stabilizers

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01

Evonik

Germany
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEvonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Grade : Parenteral

Category : Thickeners and Stabilizers

Brand Name : L-Proline

Excipient Details : L-Proline is used as a stabilizer in various injectable dosage forms such as injections, pre-filled syringes, vials, etc.

Pharmacopoeia Ref : NA

Technical Specs : Molecular weight: 115.13 g/mol

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05

SPI Pharma

U.S.A
arrow
World Vaccine Conference
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Thickeners and Stabilizers

06

DKSH

Switzerland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Grade : Oral

Category : Rheology Modifiers, Thickeners and Stabilizers

07

DKSH

Switzerland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Grade : Oral

Category : Rheology Modifiers, Thickeners and Stabilizers

10

arrow
Cophex
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Oral

Category : Fillers, Diluents & Binders

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Solubilizers

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Coating Systems & Additives

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Taste Masking

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Parenteral

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Controlled & Modified Release

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Direct Compression

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Emulsifying Agents

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Granulation

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Film Formers & Plasticizers

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Disintegrants & Superdisintegrants

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Lubricants & Glidants

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Chewable & Orodispersible Aids

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Surfactant & Foaming Agents

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Co-Processed Excipients

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Rheology Modifiers

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API Stability Enhancers

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Empty Capsules

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Coloring Agents

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Vegetarian Capsules

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Soft Gelatin

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ABOUT THIS PAGE

Looking for 63148-62-9 / Dimethicone API manufacturers, exporters & distributors?

Dimethicone manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dimethicone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dimethicone manufacturer or Dimethicone supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dimethicone manufacturer or Dimethicone supplier.

PharmaCompass also assists you with knowing the Dimethicone API Price utilized in the formulation of products. Dimethicone API Price is not always fixed or binding as the Dimethicone Price is obtained through a variety of data sources. The Dimethicone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Dimethicone

Synonyms

107-51-7, Trisiloxane, octamethyl-, Poly(dimethylsiloxane), 1,1,1,3,3,5,5,5-octamethyltrisiloxane, Dimeticone, Dimethyl-bis(trimethylsilyloxy)silane

Cas Number

63148-62-9

Unique Ingredient Identifier (UNII)

9G1ZW13R0G

Syltherm 800 Manufacturers

A Syltherm 800 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Syltherm 800, including repackagers and relabelers. The FDA regulates Syltherm 800 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Syltherm 800 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Syltherm 800 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Syltherm 800 Suppliers

A Syltherm 800 supplier is an individual or a company that provides Syltherm 800 active pharmaceutical ingredient (API) or Syltherm 800 finished formulations upon request. The Syltherm 800 suppliers may include Syltherm 800 API manufacturers, exporters, distributors and traders.

click here to find a list of Syltherm 800 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Syltherm 800 USDMF

A Syltherm 800 DMF (Drug Master File) is a document detailing the whole manufacturing process of Syltherm 800 active pharmaceutical ingredient (API) in detail. Different forms of Syltherm 800 DMFs exist exist since differing nations have different regulations, such as Syltherm 800 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Syltherm 800 DMF submitted to regulatory agencies in the US is known as a USDMF. Syltherm 800 USDMF includes data on Syltherm 800's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Syltherm 800 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Syltherm 800 suppliers with USDMF on PharmaCompass.

Syltherm 800 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Syltherm 800 Drug Master File in Japan (Syltherm 800 JDMF) empowers Syltherm 800 API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Syltherm 800 JDMF during the approval evaluation for pharmaceutical products. At the time of Syltherm 800 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Syltherm 800 suppliers with JDMF on PharmaCompass.

Syltherm 800 CEP

A Syltherm 800 CEP of the European Pharmacopoeia monograph is often referred to as a Syltherm 800 Certificate of Suitability (COS). The purpose of a Syltherm 800 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Syltherm 800 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Syltherm 800 to their clients by showing that a Syltherm 800 CEP has been issued for it. The manufacturer submits a Syltherm 800 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Syltherm 800 CEP holder for the record. Additionally, the data presented in the Syltherm 800 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Syltherm 800 DMF.

A Syltherm 800 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Syltherm 800 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Syltherm 800 suppliers with CEP (COS) on PharmaCompass.

Syltherm 800 WC

A Syltherm 800 written confirmation (Syltherm 800 WC) is an official document issued by a regulatory agency to a Syltherm 800 manufacturer, verifying that the manufacturing facility of a Syltherm 800 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Syltherm 800 APIs or Syltherm 800 finished pharmaceutical products to another nation, regulatory agencies frequently require a Syltherm 800 WC (written confirmation) as part of the regulatory process.

click here to find a list of Syltherm 800 suppliers with Written Confirmation (WC) on PharmaCompass.

Syltherm 800 NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Syltherm 800 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Syltherm 800 API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Syltherm 800 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Syltherm 800 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Syltherm 800 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Syltherm 800 suppliers with NDC on PharmaCompass.

Syltherm 800 GMP

Syltherm 800 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Syltherm 800 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Syltherm 800 GMP manufacturer or Syltherm 800 GMP API supplier for your needs.

Syltherm 800 CoA

A Syltherm 800 CoA (Certificate of Analysis) is a formal document that attests to Syltherm 800's compliance with Syltherm 800 specifications and serves as a tool for batch-level quality control.

Syltherm 800 CoA mostly includes findings from lab analyses of a specific batch. For each Syltherm 800 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Syltherm 800 may be tested according to a variety of international standards, such as European Pharmacopoeia (Syltherm 800 EP), Syltherm 800 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Syltherm 800 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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