Medical grade carnauba wax experiment application research and development test

Medical grade carnauba wax experimental application research and development of carnauba wax Baxi Zonglüla Carnauba Wax [8015-86-9] This strain is made from the Copernicia cerifera Mart.
leaves extracted and purified wax
.
【Properties】This product is light yellow or yellow powder, flakes or blocks
.
This product is easily soluble in hot xylene, dissolved in hot ethyl acetate, and almost insoluble
in water or ethanol.
Melting point The melting point of this product (general rule 0612 second method) is 80 ~ 86 °C
.
Acid number Take about 5g of this product, precision weighing, placed in a 250ml Erlenmeyer flask, add xylene 100ml, heat until completely dissolved, add ethanol 50ml and bromothymol blue indicator solution 2.
5ml, heat to clarify, while hot with ethanol to potassium hydroxide titration solution (0.
1mol / L) dropped to the solution green, and the titration result with blank test correction
.
The acid number (general rule 0713) should be 2 to 7
.
Iodine value Take about 1.
8g of this product, precision weighing, placed in 500ml of dried iodine bottle, add three 30ml, heated and dissolved in a water bath at 80 ° C ± 1 ° C, determined according to law (General 0713), the iodine value should be 5 ~ 14
。 Saponification value Take about 3g of this product, precision weighing, placed in a 500ml Erlenmeyer flask, add isopropanol - toluene (5:4) mixture solution 50ml, precision add 0.
5mol/L potassium hydroxide ethanol solution 15ml, heat reflux for 3 hours, add phenolphthalein indicator solution 1ml, while hot with hydrochloric acid titration solution (0.
5mol / L) titration, until the solution pink just faded, heated to boiling, such as the solution appears pink again, and then titrated until pink just faded, and the titration results are corrected with blank
。 The saponification value (General 0713) should be 78 to 95
.
【Identification】Take about 0.
1g of this product, add three 5ml, heat and dissolve, as a test solution (take advantage of the hot spot); take menthol, thyrol 10mg and menthol acetate 10μl, place in the same 20ml measuring bottle, add toluene diluted to the scale, shake well, as a control solution
。 According to the thin layer chromatography (General Rule 0502) test, aspirate 6 μl of the test solution and 2 μl of the control solution, respectively, on the same silica gel G thin layer plate, with ethyl acetate - three (2:98) as the unfolding agent, unfold, remove, dry, spray with the newly made 20% phosphomolybdate ethanol solution, heated at 105 °C for 10 to 15 minutes until the spots are clear, immediately examined
.
The spots shown in the control solution are, from lowest to highest, dark blue menthol, red thymol, and dark blue menthol acetate
.
The test solution should show a large spot (eicosane) between the corresponding positions of menthol and thymol, under which multiple tiny spots are visible, multiple blue spots are displayed between the corresponding positions of thymol and menthol acetate, other spots should be shown above the above spots, the largest spot than the shift value (Rf) should be clear, and the origin should be blue
。 【Check】The clarity and color of the solution Take 0.
1g of this product, add three 10ml, heat to dissolve, check according to law (general rule 0901 and general rule 0902), the solution should be clear and colorless; if color, compare with the same volume of control liquid (take 1.
0ml of potassium dichromate liquid for color, add 15ml of water, shake well, that is, to obtain), not deeper
.
Blazing residue Take 1.
0g of this product, determine according to law (General Rule 0841), and the residual residue shall not exceed 0.
25%.

Heavy metals Take the residue left under the incineration residue and inspect it according to law (General Rule 0821), and the heavy metal content shall not exceed 20
parts per million.
【Category】Pharmaceutical excipients, coating materials and release blockers, etc
.
【Storage】Sealed and preserved
.