Overview of Medicinal Hydroxypropyl Ester

CP2025 CDE filing A 500g/bottle 25kg/barrel

CP2025 CDE filing A 500g/bottle 25kg/barrel

Medicinal hydroxyphenyl propyl ester

Medicinal hydroxyphenyl propyl esterQiangbenzhiPropyl Hydroxybenzoate C10H12O3 180.20 [94-13-3] This product is 4-hydroxybenzoic acid propyl ester. According to the dry product calculation, the content of C10H12O3 should be 98.0%~102.0%.

【 Appearance 】 This product is a white or off white crystalline or crystalline powder.

This product is soluble in methanol or medium, slightly soluble in hot water, and almost insoluble in water.

The melting point of this product (General Rule 0612) is 96~99 ℃.

【 Identification 】

(1) In the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with that of the main peak of the reference solution.

(2) Take this product, dissolve and dilute it to prepare a solution containing approximately 5 μ g per 1ml, and measure it using UV visible spectrophotometry (General Rule 0401). The maximum absorption is at a wavelength of 258nm.

(3) The infrared absorption spectrum of this product should be consistent with the reference spectrum (spectrum set 852).

【 Check 】 Acidity: Take 2.0ml of the solution under the clarity and color items, add 2ml and 5ml of water, shake well, add 2 drops of bromocresol green indicator solution, titrate with titrant (0.1mol/L) until it turns blue, and the volume of titrant consumed (0.1mol/L) should not exceed 0.1ml

Clarity and color of solution

Take 1.0g of this product, dissolve it in 10ml, and check according to the regulations (General Rule 0901 and General Rule 0902). The solution should be clear and colorless; If the color appears, it should not be darker compared to the yellow or yellow green No.1 standard colorimetric solution (General Rule 0901, Method 1).

Take 2.0g of chloride, add 50.0ml of water, heat in an 80 ℃ water bath for 5 minutes, cool, and filter; Take 5.0ml of continuous filtrate and check according to the regulations (General Rule 0801). Compared with the control solution made from 7.0ml of standard sodium chloride solution, it should not be more concentrated (0.035%).

Take 25.0ml of continuous filtrate under the chloride category for sulfate, and check according to the regulations (General Rule 0802). Compared with the control solution made from 2.4ml of standard potassium sulfate solution, it should not be more concentrated (0.024%).

The function of flow aids and anti caking agents is to increase powder flow rate and reduce powder aggregation and clumping. Flow aids and anti caking agents are usually fine powders of inorganic substances. They are insoluble in water but not hydrophobic. Some of these substances are complex hydrates. Common flow aids and anti caking agents include fine inorganic powders such as talc powder and micro silica gel.

Flow aids can adsorb on the surface of larger particles, reducing inter particle adhesion and cohesion, and improving particle flowability. In addition, the flow aid can be dispersed between large particles to reduce friction. Anti caking agents can absorb moisture to prevent the formation of particle bridges in clumping phenomena.

The functional indicators of flow aids and anti caking agents include:

(1) Particle size and particle size distribution (General Rule 0982);

(2) Surface area;

(3) Powder flowability;

(4) Absorption rate, etc.