Injectable grade polyethylene glycol PEG300 Use Properties

Injectable grade polyethylene glycol PEG300 Use PropertiesPoly ethylene glycol 300 This product is a white granule
.

Soluble in water, soluble in certain organic solvents
.

Its solution has high viscosity at low concentrations, can be processed by calendering, extrusion, casting and other ways, is a thermoplastic resin, with good
compatibility with other resins.

Resistant to bacterial erosion and less
hygroscopicity in the atmosphere.

This product is a colorless or almost colorless viscous liquid, or a translucent waxy soft object; Slightly smelly
.

This product is easily soluble in water or ethanol and insoluble
in B.

The freezing point of this product (general rule 0613) is 33 ~ 38 ° C
.

The viscosity of this product is taken from 25.
0g, placed in a 50ml measuring flask, dissolved with water and diluted to the scale, shaken well, measured by law with a Pinnacle viscometer with a capillary inner diameter of 0.
8mm (general 0633 first method), the kinematic viscosity at 401 is 8.
5~11.
0mm2/s
.

【Inspection】 Average molecular weight Take this product 1.
2g, precision weighing, place in a dried 250ml stoppered Erlenmeyer flask, precision add phthalic anhydride pyridine solution (take phthalic anhydride 14g, dissolved in anhydrous pyridine 100ml, place overnight, spare) 25ml, shake well, add a small amount of anhydrous pyridine to the edge of the erlenmeyer flask, place in a boiling water bath, heat for 30 minutes, take out cooling, and precisely add sodium hydroxide titration solution (0.
5mol/L) 50ml Taking the pyridine solution of phenolphthalein (1→100) as an indicator, titrate with sodium hydroxide titration solution (0.
5mol/L) to become red, and correct
the results of the titration with a blank test.

The product of the test supply (g) and 4000, divided by the volume (ml) of the depleted sodium hydroxide titration solution (0.
5mol/L), that is, the average molecular weight of the test product should be 285 to 315
.

PH Take 1.
0g of this product, add 20ml of water to dissolve, determine according to law (general 0631), pH value should be 4.
5 ~ 7.
5
.

The clarity and color of the solution Take 5.
0g of this product, add 50ml of water to dissolve, check according to law (General 0901 and General Principle 0902), the solution should be clear and colorless; if it is turbid, it shall not be more concentrated compared with the No.
2 turbidity standard liquid (General 0902 First Method); if the color is developed, it shall not be deeper
than that of the yellow No.
2 standard colorimetric solution (General Principle 0901 First Method).

Ethylene glycol, diethylene glycol, triethylene glycol Take 4.
0g of this product, precisely weighed, placed in a 100ml measuring bottle, precisely add the internal standard solution (take the appropriate amount of 1,3-butanediol, dilute it with absolute ethanol to a solution containing about 4mg per 1ml) 1.
0ml, add absolute ethanol dilution to the scale, shake well, as a test solution; take another ethylene glycol, diethylene glycol and triethylene glycol control appropriate amount, precision weighing, add absolute ethanol dilution to make each 1ml containing ethylene glycol, diethylene glycol, A control solution of 4 mg each of triethylene glycol is stored
.

Then take 1.
0ml of the solution, put it in a 100ml measuring bottle, add 1.
0ml of the internal standard solution, add absolute ethanol to dilute to the scale, shake well, as a control solution
.

Photometric chromatography (General 0521) test
.

Take 50% phenyl-50% methyl polysiloxane as the fixative solution (30m×0.
53mm, 1 μm), start at 60 °C, maintain for 5 minutes, heat up to 110 °C at a rate of 5 °C per minute, maintain for 5 minutes, then warm up to 170 °C at a rate of 15 °C per minute, maintain for 5 minutes, then heat up to 280 °C at a rate of 35 °C per minute, maintain for 40 minutes (adjust the time according to the separation situation).


The inlet temperature is 270 °C, and the hydrogen flame ionization detector temperature is 290 °C
.

1 μl of the test solution and 1 μl of the control solution were taken, and the chromatogram was recorded
separately.

According to the internal standard method, the content of ethylene glycol, diethylene glycol and triethylene glycol shall not exceed 0.
1%.
Ethylene oxide and dioxane take 1g of this product, precision weighing, placed in the top empty bottle, precision added water 1.
0ml, sealed, shaken well, as a test solution
.

Take an appropriate amount of the aqueous ethylene oxide solution control in a precise amount, dilute it with water to make a solution containing about 2 μg per 1 ml, as a control solution
for ethylene oxide.

Take an appropriate amount of dioxane control, weigh it precisely, and make a solution containing about 20 μg per 1ml with water as a dioxohexacyclic control solution
.

Take 1g of this product, precise weighing, placed in a top empty bottle, precision add ethylene oxide control solution and dioxane control solution 0.
5ml each, seal, shake well, as a control solution
.

Precisely take 0.
5ml of ethylene oxide control solution and dioxane control solution in a top empty bottle, add 0.
1ml of newly prepared 0.
001% acetaldehyde solution, seal, shake well, as a system suitability (sensitivity) solution
.

According to the gas chromatography (general rule 0521) test, 5% phenyl-95% methyl polysiloxane as the fixative solution, the starting temperature is 35 °C, maintained for 5 minutes, warmed to 180 °C at a rate of 5 °C per minute, and then heated up at a rate of 30 °C per minute to 250 °C, maintained for 5 minutes (adjust the time according to the separation situation).


The inlet temperature is 150 °C, the hydrogen flame ionization detector temperature is 250 °C, the headspace equilibrium temperature is 70 °C, and the equilibrium time is 45 minutes
.

Take the system suitability (sensitivity) solution headspace injection, adjust the detection sensitivity so that the signal-to-noise ratio of ethylene oxide and dioxane peak is greater than 5, and the separation degree of acetaldehyde peak and ethylene oxide peak is not less than 2.
0
.

Take the test solution and the control solution headspace injection respectively, and repeat the injection at least 3 times
.

The relative standard deviation of the peak area of ethylene oxide should not exceed 15%, the relative standard deviation of the peak area of dioxane should not exceed 10%, according to the standard addition method, ethylene oxide should not exceed 0.
0001%, and the dioxane should not exceed 0.
001%.
Formaldehyde Take 1g of this product, precise weighing, add 0.
6% sodium discoloration solution 0.
25ml, after cooling in ice water, add sulfuric acid 5ml, shake well, stand for 15 minutes, slowly quantitative transfer to a 25ml measuring bottle containing 10ml of water, let it cool, slowly add water to the scale, shake well, as a test solution
.

Take an appropriate amount of formaldehyde solution, precise weighing, placed in a 100ml measuring bottle, dilute with water to the scale, make a solution containing 1mg of formaldehyde per 1ml, take 1ml of precision quantity, place it in a 100ml measuring bottle, dilute it with water to the scale; Take 1 ml of precision amount, from "add 0.
6% sodium discolorate solution 0.
25 ml", operate in the same way, as a control solution
.

Take the above two solutions, according to the ultraviolet-visible spectrophotometry (General Principle 0401), determine the absorbance at a wavelength of 567 nm, and correct
it with a blank solution operated by the same method.

The absorbance of the sample solution shall not be greater than the absorbance of the control solution (0.
001%)
.

Moisture Take 2.
0g of this product, according to the moisture determination method (General Principle 0832 First Method 1), the moisture content shall not exceed 1.
0%.
Reducing substance Take 1.
0g of this product, place it in a 25ml colorimetric tube, add 1ml of resorcinol solution, dissolve (heat if necessary), add 2ml of hydrochloric acid, leave for 5 minutes, and compare with the same volume of orange-red No.
2 standard colorimetric solution (general 0901 first method), not deeper
.

Blazing residue Take this product, check according to law (General Principle 0841), and the residual residue shall not exceed 0.
1%.
Heavy metals Take 4.
0g of this product, add hydrochloric acid solution (9→1000) 5ml and an appropriate amount of water, dissolve, adjust the pH value to 3.
0 ~ 4.
0 with dilute acetic acid or ammonia test solution, and then add water to dilute to 25ml, check according to law (general 0821 first law), heavy metals shall not exceed 5
parts per million.

Arsenic salt Take 0.
67g of this product, put it in a Kjeldahl flask, add 5ml of sulfuric acid, digest it with a low fire to carbonize, control the temperature not exceeding 120 ° C (sulfuric acid can be added if necessary, the total amount does not exceed 10ml), carefully add concentrated hydrogen peroxide solution drop by drop, stop the reaction, continue to heat, and add concentrated hydrogen peroxide solution dropwise to the solution colorless, cool, add water 10ml, evaporation to the occurrence of smoke to remove the hydrogen peroxide, add 5ml of hydrochloric acid with an appropriate amount of water, check according to law (General Principle 0822 First Law), should comply with the provisions (0.
0003%)
.

Bacterial endotoxin Take this product, check according to law (General Principle 1143), the amount of endotoxin contained in each 1mg of polyethylene glycol 300 should be less than 0.
012EU
.