What Is Econazole Nitrate?

Econazole nitrate is a white or slightly yellow crystalline or crystalline powder, which is odorless and belongs to antifungal drugs. Econazole nitrate is commonly used in the determination of econazole nitrate in econazole nitrate. The concentration of this solution is calculated based on the consumption of this solution and the amount of potassium hydrogen phthalate taken.

Econazole nitrate

Econazole nitrate is a white or slightly yellow crystalline or crystalline powder, which is odorless and belongs to antifungal drugs. Econazole nitrate is commonly used in the determination of econazole nitrate in econazole nitrate. The concentration of this solution is calculated based on the consumption of this solution and the amount of potassium hydrogen phthalate taken.

Chinese name

Econazole nitrate

Molecular weight

444.70

Page number

2000 edition two-847

Molecular formula

C18H15Cl3N2O.HNO3

English name: Econazole Nitrate

Chinese aliases: econazole, clobenzimidazole, clobenzimidazole, clobenzimidazole nitrate, diclofenacazole nitrate,

Diclofenazole, ringworm

CAS number: 24169-02-6; 68797-31-9 ^[1]

The product is white or light yellow crystalline or crystalline powder; odorless.

This product is easily soluble in methanol, slightly soluble in chloroform, and very slightly soluble in water.

Melting point The melting point of this product (Appendix VI C) is 163 to 167 ° C. It will decompose at the same time when melting.

(1) Take this product, add a 0.1mol / L hydrochloric acid solution-methanol (1: 9) mixed solution to make a solution containing 0.4mg per 1mg, and measure it by spectrophotometry (Appendix IV A) at 265nm, 272nm With a maximum absorption at a wavelength of 280nm.

(2) Take about 3mg of this product, add 2 drops of sulfuric acid and 1 drop of diphenylamine test solution, it should be dark blue.

(3) The infrared absorption spectrum of this product should be consistent with the control spectrum (spectrum set 475).

(4) Take about 20mg of this product and perform organic destruction according to the oxygen bottle combustion method (Appendix C). Use 5ml of sodium hydroxide test solution as the absorption solution. After the combustion is complete, shake it thoroughly and dilute it to 20ml with water. Dilute nitric acid acidified, and the absorption solution showed chloride identification (Appendix III).

For acidity, take 1g of the product, add 50ml of water, heat in a 70 ° C water bath for 5 minutes, immediately cool, filter, and measure the filtrate according to law (Appendix VI H). The pH value should be 3.0 to 4.5.

Take the product after losing weight and dry it at 105 to constant weight. The weight loss should not exceed 0.5% (Appendix L). Take 1.0g of the residue after ignition and check it according to law (Appendix N). The residual residue shall not exceed 0.1%.

The heavy metal shall be taken as the residue left under the burning residue, and shall be inspected in accordance with the law (Appendix H Second Law). The content of heavy metal shall not exceed 20 parts per million.

Relevant substances take this product, add methanol to make a solution containing 20mg per 1ml, as the test solution; take a precise amount, dilute with methanol to a solution containing 100g per 1ml, as a control solution. According to the thin-layer chromatography (Appendix V B) test, draw 25 l of each of the two solutions, and point them on the same silica gel G thin-layer plate with n-hexane-chloroform-methanol-concentrated ammonia solution (60: 30: 10: 1 ) Is a developing agent. After the development, it is dried and smoked with iodine vapor. The spot color of the test solution must be darker than that of the control solution.

Take about 0.3g of this product, accurately weigh it, add 30ml of glacial acetic acid to dissolve it, use potentiometric titration (Appendix A), titrate with perchloric acid titrant (0.1mol / L), and use the blank test Correction. Each 1ml of perchloric acid titration solution (0.1mol / L) is equivalent to 44.47mg of C18H15Cl3N2O.HNO3.

Method name:

Econazole Nitrate-Determination of Econazole Nitrate-Potentiometric Titration

Application:

This method uses potentiometric titration to determine the content of econazole nitrate (C18H15Cl3N2O · HNO3) in econazole nitrate.

This method is suitable for the determination of econazole nitrate in econazole nitrate.

Method principle:

The test product is accurately weighed, dissolved by adding glacial acetic acid, and titrated with perchloric acid titration solution according to the potentiometric titration method. The titration results were corrected by a blank test. Each 1 mL of perchloric acid titrant (0.1 mol / L) was equivalent to 44.47 mg of C18H15Cl3N2O · HNO3.

Reagent:

1. Water (newly boiled to room temperature)

Glacial acetic acid

3. Perchloric acid titrant (0.1mol / L)

4. Reference potassium hydrogen phthalate

5. Anhydrous glacial acetic acid

6. Crystal violet indicator liquid

equipment:

Sample preparation:

1. Perchloric acid titrant (0.1mol / L)

Preparation: Take 750mL of anhydrous glacial acetic acid (calculated with water content, add 5.22mL of acetic anhydride per 1g of water), add 8.5mL of perchloric acid (70 ~ 72%), shake well, let cool, add an appropriate amount of anhydrous glacial acetic acid 1000mL, shake well and leave for 24 hours. If the test sample is easily acetylated, the water content of the solution must be determined by the moisture measurement method, and then the water content of the solution is adjusted to 0.01% ~ 0.2% with water and acetic anhydride.

Calibration: Take about 0.16g of standard potassium hydrogen phthalate dried to constant weight at 105 , accurately weigh, add 20mL of anhydrous glacial acetic acid to dissolve, add 1 drop of crystal violet indicator solution, and slowly titrate with this solution to Blue, and the titration results are corrected with a blank test. Each 1mL of perchloric acid titration solution (0.1mol / L) is equivalent to 20.42mg of potassium hydrogen phthalate. Calculate the concentration of this solution based on the consumption of this solution and the amount of potassium hydrogen phthalate taken.

Crystal violet indicator liquid

Take 0.5 g of crystal violet and add 100 mL of glacial acetic acid to dissolve.

Storage: Place in a brown glass bottle and keep tightly closed.

Steps:

Take 0.3g of this product, accurately weigh, add 30mL of glacial acetic acid to dissolve, titrate with perchloric acid titration solution (0.1mol / L) according to the potentiometric titration method. The titration results were corrected by a blank test. Each 1 mL of perchloric acid titrant (0.1 mol / L) was equivalent to 44.47 mg of C18H15Cl3N2O · HNO3.

Note 1: "Precision weighing" means that the weighed weight should be accurate to one thousandth of the weight. Precision requirements.

Note 2: "Determination of moisture" uses the drying method, taking 2 to 5 g of the test sample, and spreading it in a flat weighing bottle that is dry to constant weight, the thickness does not exceed 5 mm, and the loose test sample does not exceed 10 mm. Open the bottle cap and dry at 100 ~ 105 ° C for 5 hours. Place the cap on the dryer, cool it for 30 minutes, and weigh it precisely. Then dry it at the above temperature for 1 hour, cool, and weigh until two times in a row. The difference in weighing does not exceed 5 mg. Calculate the moisture content (%) in the test product based on the weight lost. ^[2]

Antifungal.

Keep sealed.

(1) Econazole nitrate ointment

(2) Econazole nitrate suppository

(3) Econazole nitrate spray

(4) Econazole nitrate solution