Medicinal grade carbomer 940cas9007-20-9 use

Pharmaceutical grade Carbomer 940cas9007-20-9 use polyacrylic acid, referred to as PAA, alias 2-acrylic homopolymer, acrylic resin coating, acrylic resin, acrylic monomer polymer, acrylic modified resin, acrylic resin emulsion, is a water-soluble acrylic polymer, also soluble in some polar solvents, such as methanol, diane and ethylene glycol
.

Ionization constant Chemicalbook 4.
75
.

Because the molecule contains a large number of carboxyl groups, it can react with bases, alcohols, amines, and can also be dehydrated, degraded and complexed
.

Can be used as thickeners, dispersants, flocculants, adhesives and film formers, etc.
, widely used in
coatings, plastics, paper, textiles, rubber, food, medicine, cosmetics and water treatment and other industries.

【Inspection】 Acidity Take 0.
1g of this product, add 10ml of water to make the swelling evenly dispersed, check according to law (general 0631), pH value should be 2.
5 ~ 3.
5
.

Viscosity Take 2.
5g of this product dried for 1 hour under 80 °C decompression, add 500ml of water while stirring, continue to stir at a speed of 800 rpm until dispersed evenly, reduce the stirring speed to 600 rpm, continue to stir for 20 minutes, reduce the stirring speed to 300 rpm, with 18% The sodium hydroxide solution is adjusted to a pH of 7.
3 to 7.
8, it is allowed to stand in a 25 ° C water bath for 1 hour, centrifuged at a speed of 3000 revolutions per minute for 4 minutes (the centrifugal time can be appropriately increased to remove air bubbles), the appropriate rotor and speed are selected according to the following table, and the dynamic viscosity is determined according to law (General 0633 Third Method Rotor Type Rotary Viscometer).

Type A should be 4 to 11 Pa·s, Type B should be 25 to 45 Pa·s, and Type C should be 40 to 60 Pa·s
.

Residual solvent Ethyl acetate and cyclohexane (measured when used in the production process) Take about 0.
2g of this product, precision weighing, placed in a top empty bottle, precision added 5ml of dimethyl sulfoxide, sealed, as a test solution; take the appropriate amount of ethyl acetate and cyclohexane, precisely weighed, quantitatively diluted with dimethyl sulfoxide into a mixed solution containing ethyl acetate 0.
2mg and cyclohexane 0.
12mg per 1ml, the precision amount is taken 5ml, placed in the top empty bottle, sealed, as a control solution
。
According to the residual solvent assay (General 0861 second method), with 100% dimethicone (or similar in polarity) as the capillary column of the fixative solution, the program is heated up, the starting temperature is 40 ° C, maintained for 3 minutes, at a rate of 5 ° C per minute to 120 ° C, maintained for 20 minutes, then warmed to 220 ° C at a rate of 20 ° C per minute, maintained for 3 minutes, and then heated up at a rate of 20 ° C per minute to 240 ° C, maintained for 8 minutes; Inlet temperature 260 °C; Detector temperature 260 °C; The equilibration temperature of the head-empty bottle is 85 °C, and the equilibration time is 90 minutes
.

Take the control solution and the test solution and inject it into the headspace respectively
.

According to the external standard method, the peak area is calculated, and the ethyl acetate shall not exceed 0.
5%, and the cyclohexane shall not exceed 0.
3%.
Benzene take an appropriate amount of benzene, precise weighing, quantitative dilution with dimethyl sulfoxide to make a solution containing 1.
0mg of benzene per 1ml, precise amount of appropriate amount, quantitative dilution with water to make a solution containing 0.
5 μg of benzene per 1ml, as a benzene storage solution
.

Take this product about 250mg, precision weighing, placed in the top empty bottle, precision add 2% sodium chloride solution 10.
0ml, mechanical mixing evenly (about 30 minutes), sealed, as a test solution, this solution should be sampled within 3 hours after preparation; take about 250mg of this product, precision weighing, placed in the top empty bottle, precision added 2% Sodium chloride solution 9.
0ml, mechanical mixing evenly (about 30 minutes), precision add benzene storage solution 1ml, mechanical mixing evenly (about 1 minute), sealed, as a control solution
.

According to the residual solvent assay (general rule 0861 second method), with 6% cyanopropylphenyl -94% dimethicone as the capillary column of the fixative solution, the program is heated up, the starting temperature is 40 °C, maintained for 20 minutes, at a rate of 10 °C per minute to 240 °C, maintained for 20 minutes; Inlet temperature 140 °C, detector for hydrogen flame ionization detector, temperature 250 °C; The balance temperature of the headspace bottle is 80 °C, the balance time is 60 minutes, and the headspace injection is injected
.

Taking the control solution as the system suitability solution, the peak chromatographic height of benzene should be more than 10 times the baseline noise, and the peak area of benzene should not exceed 15%
relative to the standard deviation of three consecutive injections.

Take the control solution and the test solution to headspace injection, the peak area of benzene in the test solution shall not be greater than half of the peak area of benzene in the control solution (0.
0002%)
.

Acrylic take about 50mg of this product, precision weighing, placed in a stopper centrifuge tube, precision add 2.
5% potassium aluminum sulfate solution 5ml, capping, at 50 °C, at a speed of 250 revolutions per minute for 1 hour, centrifuge at 10,000 revolutions per minute for 10 minutes, filter, filtrate as a test solution; Take an appropriate amount of acrylic acid control, weigh it precisely, dissolve it with 2.
5% aluminum potassium sulfate solution and quantitatively dilute it into a solution containing 25 μg per 1 ml as a control solution
.

According to the high performance liquid chromatography (general principle 0512), octadecyl silane bonded silica gel is used as a filler; Take potassium dihydrogen phosphate solution (take 1.
36g of potassium dihydrogen phosphate, add 1000ml of water to dissolve, and adjust the pH value with phosphoric acid to 3.
0±0.
1)-methanol (80:20) as the mobile phase; Detection wavelength 200 nm
.

Precisely measure 10 μl of the control solution and the test solution, inject it into the liquid chromatograph, and calculate the peak area according to the external standard method, not more than 0.
25%.
Loss on drying Take this product, dry at 80 °C under reduced pressure for 1 hour, the weight loss shall not exceed 2.
0% (General 0831).
Blazing residue Take 1.
0g of this product, check according to law (General Principle 0841), and the residual residue shall not exceed 2.
0%.
Heavy metals Take the residue left under the burning residue and inspect it according to law (General Principle 0821 Second Law), and the heavy metal shall not exceed 20 parts per million
.