Name | DIOXOPROMETHAZINE HCl |
Synonyms | Prothanon Dioxoprome Dioxypromethazine DIOXOPROMETHAZINE HCl DIOXOPROMETHAZINE HCL 9,9-Dioxopromethazine Dioxopromethaxine Hydrochloride 10-[2-(Dimethylamino)propyl]-10H-phenothiazine 5,5-dioxide N,N,α-Trimethyl-10H-phenothiazine-10-ethanamine 5,5-dioxide 1-(5,5-Dioxido-10H-phenothiazin-10-yl)-N,N-dimethylpropan-2-amine 10H-phenothiazine-10-ethanamine, N,N,alpha-trimethyl-, 5,5-dioxide 10H-Phenothiazine-10-ethanamine, N,N,alpha-trimethyl-, 5,5-dioxide (9CI) |
CAS | 13754-56-8 |
EINECS | 1308068-626-2 |
InChI | InChI=1/C17H20N2O2S/c1-13(18(2)3)12-19-14-8-4-6-10-16(14)22(20,21)17-11-7-5-9-15(17)19/h4-11,13H,12H2,1-3H3 |
Molecular Formula | C17H20N2O2S |
Molar Mass | 316.42 |
Density | 1.224 |
Melting Point | 127-129℃ |
Boling Point | 478.5±34.0 °C(Predicted) |
Flash Point | 243.2°C |
Solubility | Chloroform (Slightly), Methanol (Slightly, Heated) |
Vapor Presure | 2.57E-09mmHg at 25°C |
Appearance | Solid |
Color | Light Beige |
pKa | 8.88±0.50(Predicted) |
Storage Condition | Refrigerator |
Refractive Index | 1.605 |
Physical and Chemical Properties | White or yellowish powder or crystalline powder, odorless, bitter taste. Soluble in water, slightly soluble in ethanol. |
This product is the hydrochloride salt of 10-(2-dimethylamino-propyl) phenothiazine-5, 5-dioxide. The content of C17H20N202S • HC1 shall not be less than 99.0% based on dry products.
take this product, precision weighing, add 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing 10ug per 1 ml, and the absorbance was measured at the wavelength of 264nm by UV-visible spectrophotometry (General rule 0401), the absorption coefficient is 350 to 370.
take 0.5g of this product, add 25ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 4.2~5.1.
take 0.2g of this product, add water 10ml to dissolve, the solution should be clear and colorless; If the color is colored, compared with the yellow 2 Standard Colorimetric solution (General rule 0901 first method), not deeper.
take 1.2g of this product and check it according to law (General rule 0802). Compared with the control solution made of 3ml of standard potassium sulfate solution, it should not be more concentrated (0.025%).
take an appropriate amount of this product, add the mobile phase to dissolve and dilute to make a solution containing 0.3mg per lml as a test solution; Take an appropriate amount for precision measurement, A solution containing 3 WDS per 1ml was prepared as a control solution by quantitative dilution with the mobile phase. According to the test of high performance liquid chromatography (General rule 0512), silica gel was bonded with eighteen alkyl silane as the filler; 0.05 mL of acetate buffer solution (mol/L ammonium acetate solution) was added with 1ml of triethylamine, the pH was adjusted to 6.5 with acetic acid)-acetonitrile (75:25) as the mobile phase; The detection wavelength was 258mn. The number of theoretical plates is not less than 5000 based on the dioxopromethazine peak. 20 u1 of the test solution and the control solution were respectively injected into the human liquid chromatograph, and the chromatogram was recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) the area of the main peak of the control solution, and the sum of the areas of each impurity peak shall not be greater than the area of the main peak of the control solution (1.0%).
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
take about 0.3g of this product, precision weighing, add 25ml of glacial acetic acid and 10ml of Mercury acetate test solution, dissolve at a slight temperature, cool, add 1~2 drops of crystal violet indicator solution, with perchloric acid titration solution (0.1 mol/L) titration to a blue color of the solution, and the results of the titration were corrected by a blank test. Each 1 ml of perchloric acid titration solution (0.1 mol/L) corresponds to 35.29mg of c17h20n2o2s-hc1.
antitussive drugs.
light shielding, sealed storage.
This product contains dioxopromethazine hydrochloride (C17H20N202S • HC1) should be 90.0% ~ 110.0% of the label amount.
This product is a white tablet or sugar-coated tablet, White after removing the coating.
take 12 tablets of this product, put it in a 200ml measuring flask, add 0.1 mol/L hydrochloric acid solution about 150ml, shake to dissolve dioxopromethazine hydrochloride, with 0. Dilute 1 mol/L hydrochloric acid solution to the scale, shake well, filter, Take 5ml of continuous filtrate accurately, put it in a 100ml measuring flask, use 0.1 mol/L hydrochloric acid solution diluted to the scale, shake, according to UV-visible spectrophotometry (General 0401), at the wavelength of 264nm absorbance, the absorption coefficient of C17H20N202S. HC1 was calculated as 362.
with dioxopromethazine hydrochloride.
5mg
light shielding, sealed storage.