Dimeticone or Dimethicone Specifications of Commercial Pure & BP Ph Eur USP NF Grade Manufacturers & Exporters
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Dimeticone or Dimethicone CAS Number 9006-65-9 or 9006-75-9 or 9016-00-6 or 63148-62-9
Specifications of Dimethicone USP NF Grade:
α-(Trimethylsilyl)-ω-methylpoly[oxy(dimethylsilylene)] CAS 9006-65-9.
DEFINITION
Dimethicone is a mixture of fully methylated linear siloxane polymers containing repeating units of the formula: [-(CH3)2SiO-]n stabilized with trimethylsiloxy end-blocking units of the formula: [(CH3)3SiO-] wherein n has an average value such that the corresponding nominal viscosity is in a discrete range between 20 and 30,000 centistokes. It contains NLT 97.0% and NMT 103.0% of polydimethylsiloxane ([-(CH3)2SiO-]n).
The requirements for viscosity, specific gravity, refractive index, and loss on heating differ for the several types of Dimethicone..
IDENTIFICATION
A. The IR absorption spectrum of the Sample exhibits maxima only at the same wavelengths as that of the Standard, obtained as directed in the Assay.
ASSAY
To pass the test by Mid-Infrared Spectroscopy.
Acceptance criteria: percentage of polydimethylsiloxane ([-(CH3)2SiO-]n) in the Dimethicone 97.0%-103.0%
Specific Gravity: As specified in monograph.
Refractive Index: As specified in monograph.
Acidity:
Sample: 15.0 g.
Analysis: Dissolve the Sample in a mixture of 15 mL of toluene and 15 mL of butyl alcohol, previously neutralized to bromophenol blue TS, and titrate with 0.050 N alcoholic potassium hydroxide to a bromophenol blue endpoint.
Acceptance criteria: NMT 0.10 mL of 0.050 N alcoholic potassium hydroxide is required.
Loss on Heating:
Sample: 1 g
Analysis: Preheat an open aluminum vessel (60 mm in diameter and 10 mm high) at 150C for 30 min, and allow to cool to room temperature. Tare the vessel, transfer the Sample to it, heat at 150C in a circulating air oven for 2 h, and allow to come to room temperature in a desiccator before weighing.
Acceptance criteria: As specified in monograph.
Bacterial Endotoxins Test: (where it is intended for use in coating containers that come in contact with articles for parenteral use)
Sample: 1.0 mL
Analysis: Mix the Sample with 4.0 mL of polydimethylsiloxane having a viscosity of 0.65 centistokes, previously tested and shown to be negative for bacterial endotoxins, by mixing on a vortex mixer for 1 min in an extraction tube. Add 10 mL of water, and mix on a vortex mixer for NLT 60 min. Allow the layers to separate, and use the lower aqueous layer as the sample.
Acceptance criteria: It contains NMT 1.0 USP Endotoxin Unit/mL, equivalent to NMT 10 Endotoxin Units/mL of the Dimethicone taken.
Viscosity-Capillary Methods and Viscosity-Rotational Methods:
Analysis: Determine the viscosity of Dimethicone having a nominal viscosity of less than 1000 centistokes at 25 ± 0.1°, using a capillary viscometer. Determine the viscosity of Dimethicone having a nominal viscosity of 1000 centistokes or greater at 25 ± 0.1°, using a rotational viscometer.
Acceptance criteria: As specified in monograph.
Specifications of Dimeticone BP Grade
Ph Eur --- CAS 9006-75-9
Action and use: Antifoaming agent; water repellent. When dimethicone is demanded, Dimeticone shall be supplied.
DEFINITION
Poly(dimethylsiloxane) obtained by hydrolysis and polycondensation of dichlorodimethylsilane and chlorotrimethylsilane. Different grades of dimeticone exist which are distinguished by a number indicating the nominal kinematic viscosity placed after the name.
Their degree of polymerisation (n = 20 to 400) is such that their kinematic viscosities are nominally between 20 mm2·s-1 and 1300 mm2·s-1.
Dimeticones with a nominal viscosity of 50 mm2·s-1 or lower are intended for external use only.
CHARACTERS
Appearance: Clear, colourless liquid of various viscosities.
Solubility: Practically insoluble in water, very slightly soluble or practically insoluble in anhydrous ethanol, miscible with ethyl acetate, with methyl ethyl ketone and with toluene.
IDENTIFICATION
A. It is identified by its kinematic viscosity at 25C (see Tests).
B. Infrared absorption spectrophotometry.
C. Heat 0.5 g in a test-tube over a small flame until white fumes begin to appear. Invert the tube over a 2nd tube containing 1 ml of a 1 g/l solution of chromotropic acid sodium salt in sulphuric acid so that the fumes reach the solution. Shake the 2nd tube for about 10 s and heat on a water-bath for 5 min. The solution is violet.
D. In a platinum crucible, prepare the sulphated ash using 50 mg. The residue is a white powder that gives the reaction of silicates.
TESTS
Acidity: To 2.0 g add 25 ml of a mixture of equal volumes of anhydrous ethanol and ether, previously neutralised to 0.2 ml of bromothymol blue solution and shake. Not more than 0.15 ml of 0.01 M sodium hydroxide is required to change the colour of the solution to blue.
Viscosity: 90 per cent to 110 per cent of the nominal kinematic viscosity stated on the label, determined at 25C.
Mineral oils: Place 2 g in a test-tube and examine in ultraviolet light at 365 nm. The fluorescence is not more intense than that of a solution containing 0.1 ppm of quinine sulphate in 0.005 M sulphuric acid examined in the same conditions.
Phenylated compounds: Dissolve 5.0 g with shaking in 10 ml of cyclohexane. At wavelengths from 250 nm to 270 nm, the absorbance of the solution is not greater than 0.2.
Heavy metals: Maximum 5 ppm.
Volatile matter: Maximum 0.3 per cent, for dimeticones with a nominal viscosity greater than 50 mm2·s-1, determined on 1.00 g by heating in an oven at 150 °C for 2 h. Carry out the test using a dish 60 mm in diameter and 10 mm deep.
SDS MSDS of Dimeticone or Dimethicone BP Ph Eur EP JP USP NF IP ACS Analytical Reagent FCC Food grade Manufacturers |
