Medical grade menthol experiment application for research and development test

Clinical grade menthol experiment application research and development test menthol Bohenao L-Menthol C10H20O 156.
27 [1490-04-6] or [89-78-1] This product is L-1-methyl-4-isopropylcyclohexanol-3, which is from the labial family plant Mentha haplocalyx Briq.
The fresh stems and leaves are distilled, frozen and recrystallized by water vapor
.
C10H20O should be 95.
0%~105.
0%.

【Properties】This product is a colorless needle or prism crystal or white crystalline powder; Has a special aroma of mint; The ethanol solution is mildly neutral
.
This product is very soluble in ethanol and very little soluble in water
.
Melting point The melting point of this product (general rule 0612) is 42~44°C
.
Specific curl Take this product, precision weighing, add ethanol to dissolve and quantitatively dilute to make a solution containing about 0.
1g per 1ml, determined according to law (General 0621), the specific curl is -49 ° to -50 °
.
【Identification】(1) Take 1g of this product, add 20ml of sulfuric acid to dissolve, that is, appear orange-red, and precipitate a colorless oil layer without menthol aroma (the difference with thymol)
after 24 hours.
(2) Take 50mg of this product, add 1ml of glacial acetic acid to dissolve, add 6 drops of sulfuric acid and 1 drop of nitric acid cold mixture, only appear yellowish (the difference with thymol).

【Check】Relevant substances Take an appropriate amount of this product, weigh it precisely, add absolute ethanol to dissolve and quantitatively dilute to make a solution containing about 50mg per 1ml, as a test solution; Another menthol control is taken in an appropriate amount, precisely weighed, dissolved and quantitatively diluted with absolute ethanol to make a solution containing about 0.
5mg per 1ml as a control solution
.
According to the chromatographic conditions under the content determination, where the column temperature is 110 °C, 1 μl of the control solution is injected into the gas chromatograph, the chromatogram is recorded, and the signal-to-noise ratio of the peak height of the principal component should be greater than 10; Then accurately measure 1 μl of the test solution and the control solution, inject them into the gas chromatograph respectively, and record the chromatogram to 2 times
the retention time of the principal component peak.
If there are impurity peaks in the chromatography of the test products, the sum of the peak areas of each impurity shall not be greater than the main peak area (1.
0%)
of the control solution.
No volatiles Take 2g of this product, place in an evaporation dish that has been dried to constant weight, heat it in a water bath, so that after slowly dispersing, dry to constant weight at 105 ° C, and the residual residue shall not exceed 1mg
.
Heavy metals and harmful elements According to the determination of lead, cadmium, arsenic, mercury and copper (General Rule 2321), the content of lead shall not exceed 0.
0005%, cadmium shall not exceed 0.
00003%, arsenic shall not exceed 0.
0002%, mercury shall not exceed 0.
00002%, copper shall not exceed 0.
002%.

【Content determination】Determination
by gas chromatography (General Rule 0521).
Chromatographic conditions and system suitability test Capillary columns with crosslinking bonded polyethylene glycol (or similar polarity) as fixative liquid are chromatographic columns; Column temperature is 120 °C; Inlet temperature is 250°C; The detector temperature is 250°C
.
The number of theoretical plates is not less than 10,000 according to the mint peak
.
Determination method Take 10mg of this product, precision weighing, place in a 10ml measuring bottle, add absolute ethanol to dissolve and dilute to the scale, shake well, as a test solution, precision amount of 1μl injected into the gas chromatography, record the chromatography; Another menthol control was taken and measured
by the same method.
According to the external standard method to calculate the peak area, that is, obtained
.
【Category】Medicinal excipients, flavor correctants and aromatics, etc
.
【Storage】Seal tightly and place in a cool place
.