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2、消癌平注射液中吐温-80用量的研究及质量控制2.1建立消癌平注射液中吐温-80含量的测定方法2.2建立吐温-80纯度的测定方法2.3不同厂家不同纯度的吐温-80增容效果及安全性评价 1、消癌平注射液中高分子杂质去除方法研究1.1建立GPC法测定消癌平注射液中高分子物质的方法1.2超滤前后高分子物质的去除效果研究
Polysorbate 80
Polyoxyethylene 20 Sorbitan Mono-oleate
(Ph Eur monograph 0428)
9005-65-6
Ph Eur
DEFINITION
Polysorbate 80 is a mixture of partial esters of various fatty acids, mainly oleic acid, and sorbitol and its anhydrides copolymerid with approximately 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides. The fatty acid fraction can be of vegetable or animal origin. It contains not less than 60.0 per cent of oleic acid and not less than 90.0 per cent and not more than 110.0 per cent of the content stated on the lab
el.
PRODUCTION
2-Chloroethanol, ethylene glycol and diethylene glycol
画廊英文
Not more than 10 ppm of 2-chloroethanol and not more than a total of 0.25 per cent for ethylene glycol and diethylene glycol, determined by head-space gas chromatography (2.2.28), using themethod of standard additions.
Test solution
Place 50 mg of the substance to be examined in a 20 ml vial, add 2.0 ml of 2-propanol R and clo immediately. Allow to stand for about 2 min and in any ca not more than 5 min.
Reference solution
Place 50 mg of the substance to be examined in a 20 ml vial, add 2.0 ml of a solution containing, in 2-propanol R, 0.25 mg/ml of 2-chloroethanol R, 31.25 mg/ml of ethylene glycol R and 31.25 mg/ml of diethylene glycol R and clo immediately. Allow to stand for about 2 min and in any ca not more than 5 min.
The chromatographic procedure may be carried out using:
a purge and trap head space sampler, asmbled before the chromatographic system using a stainless steel precolumn 13.6 mm long and 4 mm in internal diameter packed with ethylvinylbenzene-divinylbenzene copolymer R as trap column and helium for chromatography R as the carrier gas at a flow rate of 20 ml/min and an additional 20 ml/min as auxiliary gas. Place the vials parately on a water-bath at 110 C and begin purging within 5 min, whilst maintaining the trap column at 50 C; continue purging for 40 min. Then rai the temperature of the trap column to 210 C and inject for 5 min in the chromatographic system,
a fud-silica column 30 m long and 0.53 mm in internal diameter, the internal wall of which is coated with macrogol 20 000 for chromatography R (film thickness 1 mm),
helium for chromatography R as the carrier gas at a linear velocity of 60 cm/s, a flame-ionisation detector.
Calculate the content of 2-chloroethanol, ethylene glycol and diethylene glycol from the areas of the peaks and the concentration of the solutions.
CHARACTERS
An oily, yellowish or brownish-yellow, clear liquid, miscible with water, with ethanol, with ethyl acetate and with methanol, practically insoluble in fatty oils and in liquid paraffin.
It has a relative density of about 1.08. It has a viscosity of about 400 mPas at 25 C.
IDENTIFICATION
First identificationnervous是什么意思
B, C.
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Second identification 整机英文
A, D, E.
A. Dissolve 0.5 g in water R at about 50 C and dilute to 10 ml with the same solvent. The solution produces a copious foam on shaking. Add 0.5 g of sodium chloride R and heat the solution to boiling. The resulting cloudiness disappears during cooling to about 50 C.
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B. Examine by infrared absorption spectrophotometry (2.2.24), comparing with the Ph.Eur. reference spectrum of polysorbate 80 at the following wavelengths: 720 cm-1, 11
10 cm-1, 1250 cm-1, 1300 cm-1, 1350 cm-1, 1740 cm-1, 2850 cm-1, 2920 cm-1 and 3500 cm-1.
C. It complies with the limits of the assay.
D. To 2 ml of a 50 g/l solution, add 0.5 ml of bromine water Rbuddy. The mixture is decolorid.
E. Dissolve 0.1 g in 5 ml of methylene chloride R. Add 0.1 g of potassium thiocyanate R and 0.1 g of cobalt nitrate R. Stir with a glass rod. The solution becomes blue.
TESTS
Acid value (2.5.1)
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Not more than 2.0, determined on 5.0 g dissolved in 50 ml of the prescribed mixture of solvents.
jhcHydroxyl value (2.5.3, Method A)
imply翻译
65 to 80, determined on 2.0 g.
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Peroxide value (2.5.5)
Not more than 10.
Saponification value (2.5.6)
45 to 55, determined on 2.0 g. U 15.0 ml of 0.5 M alcoholic potassium hydroxide and dilute with 50 ml of water R before carrying out the titration.
Ethylene oxide and dioxan (2.4.25, System A)
Not more than 1 ppm of ethylene oxide and not more than 10 ppm of dioxan. When determining the dioxan content, apply a correction factor of 1/5 to the calculation.
