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Main functions and functions of pharmaceutical grade microcrystalline wax Weijingla Microcrystalline Wax [63231-60-7] This product is a mixture of straight chain hydrocarbons, branched chain hydrocarbons and cyclic hydrocarbons obtained from petroleum
.
【Properties】This product is white or off-white waxy solid
.
This product is easily soluble in medium, slightly soluble in absolute ethanol, and insoluble in water
.
Melting point The melting point of this product (General Principle 0612 Second Method) is 54~102℃
.
[Identification] (1) Take an appropriate amount of this product, put it in an evaporating dish, heat it to melt, ignite the melt, the flame is bright, and it smells of oil
.
(2) Take about 0.
5g of this product, put it in a test tube, add 0.
5g of sublimation sulfur, shake gently, mix well, heat, and introduce the generated hydrogen sulfide gas into 50ml of lead acetate test solution, and the color of the solution gradually changes from colorless to colorless is black
.
[Check] pH Take 35.
0g of this product, put it in a 250ml separatory funnel, add 100ml of boiling water, shake vigorously for 5 minutes, separate the water layer, add 50ml of boiling water, shake and wash, repeat twice, combine the aqueous layer solutions, add phenolphthalein Add 1 drop of indicator solution, boil, the solution is not micro red; take another aqueous solution prepared by the same method, add 0.
1 ml of methyl orange indicator solution, the solution is not micro red
.
Take an appropriate amount of this product for color, heat it in a water bath to melt, take 5ml of the molten solution, mix it with the same volume of control solution (1.
2ml of cobalt chloride solution for colorimetry, 1.
8ml of potassium dichromate solution for colorimetry and 2ml of water), and mix well.
) comparison, no deeper organic acids take 20.
0g of this product, put it in a 250ml conical flask, add 100ml of neutral dilute ethanol, heat under reflux for 10 minutes, add 1ml of phenolphthalein indicator solution, shake, and immediately use sodium hydroxide titration solution ( 0.
1mol/L) until the solution turns pink
.
The volume of sodium hydroxide titrant (0.
1mol/L) consumed shall not exceed 0.
4ml
.
Oils and resins Take 10.
0g of this product, add 50ml of 20% sodium hydroxide solution, heat to reflux for 30 minutes, and let it cool
.
Separate the water layer, add 200ml of dilute sulfuric acid, no oily substance and precipitation shall be formed
.
Ash content Take 1.
0g of this product and inspect it according to the law (General Rule 2302), and the remaining residue shall not exceed 0.
1%
.
Take 2.
0g of this product for heavy metals, slowly heat it to complete carbonization, ignite it at 450-550℃ to make it completely ashed, take it out, let it cool, add 2ml of hydrochloric acid, evaporate to dryness in a water bath, add 2ml of acetic acid and 15ml of water to the residue, as the test product The solution shall be inspected according to the law (the second method of general rule 0821), and the heavy metal content shall not exceed 10 parts per million
.
【Category】Pharmaceutical excipients, coating agents and controlled release carriers,
etc.
[Storage] shading, sealed preservation
.
.
【Properties】This product is white or off-white waxy solid
.
This product is easily soluble in medium, slightly soluble in absolute ethanol, and insoluble in water
.
Melting point The melting point of this product (General Principle 0612 Second Method) is 54~102℃
.
[Identification] (1) Take an appropriate amount of this product, put it in an evaporating dish, heat it to melt, ignite the melt, the flame is bright, and it smells of oil
.
(2) Take about 0.
5g of this product, put it in a test tube, add 0.
5g of sublimation sulfur, shake gently, mix well, heat, and introduce the generated hydrogen sulfide gas into 50ml of lead acetate test solution, and the color of the solution gradually changes from colorless to colorless is black
.
[Check] pH Take 35.
0g of this product, put it in a 250ml separatory funnel, add 100ml of boiling water, shake vigorously for 5 minutes, separate the water layer, add 50ml of boiling water, shake and wash, repeat twice, combine the aqueous layer solutions, add phenolphthalein Add 1 drop of indicator solution, boil, the solution is not micro red; take another aqueous solution prepared by the same method, add 0.
1 ml of methyl orange indicator solution, the solution is not micro red
.
Take an appropriate amount of this product for color, heat it in a water bath to melt, take 5ml of the molten solution, mix it with the same volume of control solution (1.
2ml of cobalt chloride solution for colorimetry, 1.
8ml of potassium dichromate solution for colorimetry and 2ml of water), and mix well.
) comparison, no deeper organic acids take 20.
0g of this product, put it in a 250ml conical flask, add 100ml of neutral dilute ethanol, heat under reflux for 10 minutes, add 1ml of phenolphthalein indicator solution, shake, and immediately use sodium hydroxide titration solution ( 0.
1mol/L) until the solution turns pink
.
The volume of sodium hydroxide titrant (0.
1mol/L) consumed shall not exceed 0.
4ml
.
Oils and resins Take 10.
0g of this product, add 50ml of 20% sodium hydroxide solution, heat to reflux for 30 minutes, and let it cool
.
Separate the water layer, add 200ml of dilute sulfuric acid, no oily substance and precipitation shall be formed
.
Ash content Take 1.
0g of this product and inspect it according to the law (General Rule 2302), and the remaining residue shall not exceed 0.
1%
.
Take 2.
0g of this product for heavy metals, slowly heat it to complete carbonization, ignite it at 450-550℃ to make it completely ashed, take it out, let it cool, add 2ml of hydrochloric acid, evaporate to dryness in a water bath, add 2ml of acetic acid and 15ml of water to the residue, as the test product The solution shall be inspected according to the law (the second method of general rule 0821), and the heavy metal content shall not exceed 10 parts per million
.
【Category】Pharmaceutical excipients, coating agents and controlled release carriers,
etc.
[Storage] shading, sealed preservation
.