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Dimethicone

Dimethicone USP NF Dimeticone BP Ph Eur Supplier, Manufacturer's Representative, CAS Number 9006-65-9 or 9006-75-9 or 9016-00-6 or 63148-62-9

CAS number : 9006-65-9 or 9006-75-9 or 9016-00-6 or 63148-62-9

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DESCRIPTION

Dimethicone USP NF:
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, as set forth in Table 1.

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.
Acceptance criteria: 97.0%–103.0%
Specific Gravity: See Table.
Refractive Index: See Table.
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 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:
To pass the test.
Acceptance criteria:  See Table.

Table
Nominal Viscosity viscosity (centistokes) Specific gravityRefractive index Loss on heating
(centistokes) Min. to Max. Min. to Max. Min. to Max. Max.
20 18 to 22 0.946 to 0.954 1.3980 to 1.4020 20.0
50 47.5 to 52.5 0.955 to 0.965 1.4005 to 1.4045 2.0
100 95 to 105 0.962 to 0.970 1.4005 to 1.40450.3
200 190 to 220 0.964 to 0.972 1.4013 to 1.4053 0.3
350 332.5 to 367.5 0.965 to 0.973 1.4013 to 1.4053 0.3
500 475 to 525 0.967 to 0.975 1.4013 to 1.4053 0.3
1000 950 to 1050 0.967 to 0.975 1.4013 to 1.4053 0.3
12,500 11,875 to 13,125 -- 1.4015 to 1.4055 2.0
30,000 27,000 to 33,000 0.969 to 0.977 1.4010 to 1.4100 2.0

Bacterial Endotoxins Test: (where it is intended for use in coating containers that come in contact with articles for parenteral use)
To pass the test.
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:
To pass the test.
Acceptance criteria: See Table.

Dimeticone BP Ph Eur
CAS Number: 9006-75-9
Action and use: Anti-foaming 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.


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