吐温80英国药典英文

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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 copolymerised 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 label.

PRODUCTION

2-Chloroethanol, ethylene glycol and diethylene glycol

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 close immediately. Allow to stand for about 2 min and in any case 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 close immediately. Allow to stand for about 2 min and in any case not more than 5 min.

The chromatographic procedure may be carried out using:

a purge and trap head space sampler, assembled 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 separately 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 raise the temperature of the trap column to 210 C and inject for 5 min in the chromatographic system,

a fused-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