Specifications for the use of pharmaceutical dimethicone in the pharmaceutical industry

Specification for the use of pharmaceutical dimethicone in the pharmaceutical industry[9006-65-9] This product is a linear polymer of dimethicone, containing 97.
0%~103.
0%
of polymerized dimethicone.
There are different viscosities
due to different degrees of polymerization.
According to the different kinematic viscosity, this product is divided into 20, 50, 100, 200, 350, 500, 750, 1000, 12500, 30000 ten models
.
【Properties】 This product is a colorless and clear oily liquid
.
This product is easily soluble in ethyl acetate or insoluble
in water or ethanol.
Relative density The relative density of this product (General 0601) should comply with the provisions
of the attached table at 25 °C.
Refractive index The refractive index of this product (General 0622) should comply with the provisions of
the attached table at 25 °C.
Viscosity The kinematic viscosity of this product at 25 °C (General rule 0633 first method, capillary inner diameter is 2mm; When the viscosity is 1000mm2/s and above, the third method shall be used) shall comply with the provisions of the
attached table.
【Identification】 (1) take 0.
5g of this product, add 0.
5ml of sulfuric acid and 0.
5ml of nitric acid, and slowly burn, that is, form white fibers, and finally leave white residue
.
(2) take 0.
5g of this product, put it in a test tube, and heat it on low heat until white smoke
appears.
Invert the tube on another tube containing 1 ml of 0.
1% sodium chromotropic acid sulfuric acid solution so that the white smoke comes into contact with the solution
.
Shake the second tube for 10 sec, heat the water bath for 5 minutes, and the solution appears purple
.
(3) The infrared light absorption spectrum of this product should be consistent with the control spectrum (spectral set 10 figures), and the absorption peak in the range of 750~850cm-1 is negligible
.
【Check】 pH take ethanol and 5ml each, shake well, add 1 drop of phenolphthalein indicator solution, add sodium hydroxide titration solution (0.
02mol/L) dropwise to slightly pink, add 1.
0g of this product, shake well; if colorless, add sodium hydroxide titration solution (0.
02mol/L) 0.
15ml, should appear pink; if pink, add sulfuric acid titration solution (0.
01mol/L) 0.
15ml, pink color should disappear
.