How to prepare chlorpheniramine maleate

  • Author:Hubei Ocean Biotech Co,.LTd
  • Release on :2016-07-19
Method name: chlorpheniramine maleate /chlorphenamine hydrogen maleate drug - chlorpheniramine maleate measurement - non-aqueous titration 
Application: This method for the determination of chlorpheniramine maleate drug chlorpheniramine maleate content using titration. 
This method is applicable chlorpheniramine maleate drug. 
Principle of the method: the test plus glacial acetic acid dissolved, add crystal violet indicator solution, titration with perchloric acid droplets given to the solution was blue-green, and titration with blank test correction, according to the titrant use to calculate Malay chlorpheniramine content. 
1. glacial acetic acid 
2. perchloric acid titration solution (0.1mol / L) 
3. crystal violet indicator solution 
4 benchmark potassium hydrogen phthalate 
Sample Preparation: 
1. perchloric acid titration solution (0.1mol / L) 
Preparation: anhydrous acetic acid (water content calculation, for every 1g of water plus acetic anhydride 5.22mL) 750mL, adding perchloric acid (70 ~ 72%) 8.5mL, shake, let cool, add the right amount of anhydrous acetic acid to make into 1000mL, shake for 24 hours. If measured by the test easy to acetylation required the determination of the solution with a moisture determination of water content, water and acetic anhydride adjusted to the liquid water content of 0.01% to 0.2%. 
Calibration: take 105 ℃ drying to constant weight basis of potassium hydrogen phthalate of about 0.16g, accurately weighed, anhydrous acetic acid 20mL dissolve, add 1 drop of crystal violet indicator solution, with the liquid slowly titrated to blue, and titration with blank test correction. Each 1mL perchloric acid titration solution (0.1mol / L) is equivalent to 20.42mg of potassium hydrogen phthalate. According to take the amount of consumption of the liquid with potassium hydrogen phthalate, calculate the concentration of the solution. 
2. crystal violet indicator solution 
Take crystal violet 0.5g, add glacial acetic acid to dissolve 100mL. 
Steps: Precision Weigh the test sample of about 0.15g, add glacial acetic acid 10mL dissolved, add 1 drop of crystal violet indicator solution, titration with perchloric acid solution (0.1mol / L) titration solution was blue-green, and titration the results of blank test correction. Each 1mL perchloric acid titration solution (0.1mol / L) is equivalent to 19.54mg of C16H19ClN2 · C4H4O4. 
Note: "Precision Weigh" means, said check the weight should be accurately referred to take the weight of one-thousandth. "Precise amount" means to measure the volume should meet the accuracy requirements of national standards for the volume pipettes. 
an examination 
Acidity to take this product 0.1g, add water 10ml dissolved, according to the determination, pH value should be 4.0 to 5.0. Related substances to take this product, add chloroform 1ml each containing 50mg of the solution, as the test solution; the precise amount of the check amount, plus chloroform solution was diluted to 0.10mg per 1ml, as a control solution. Thin layer chromatography test, draw the two solutions of 10μl, respectively, point in the same silica gel GF254 TLC plate with ethyl acetate - methanol - diluted vinegar (5: 3: 2) as developing agent, started after hanging dryness, UV light (254nm), under review. In addition to the test solution was chlorpheniramine maleate two spots, the other such as significant impurity spots, compared with the main spots of the control solution, not deeper. 
Easy Charcoal take this product 25mg, according to inspection, compared with No. 1 yellow standard color solution, not deeper. 
Drying of this product, dried at 105 ℃ to constant weight, less weight loss should not exceed 0.5%. 
Residue on ignition not more than 0.1%.

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