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Determination of solvent residues in medicinal plastic bottles

Carrie May 02,2019 Share this post:

The residual solvent of the medicinal plastic bottle refers to the raw materials of the pharmaceutical packaging material and the organic volatiles which are used in the production process but are not completely removed during the production process of the pharmaceutical packaging material. The residual amount of organic containers in the pharmaceutical packaging materials shall comply with the provisions under each variety.


medical plastic bottle

This method is based on the gas-solid balance. The sample with a certain area is placed in a sealed container. Under certain temperature and time conditions, the residual organic solvent in the sample is volatilized by heat. After reaching equilibrium, the top gas is taken. Analyze in the chromatograph to quantify retention time and quantify peak area. According to the determination method of residual container (Chinese Pharmacopoeia 2015 edition general rule 0861), the limit of residual solvent should meet the requirements under each category, and the detection limit of each solvent of stupid and stupid should not exceed 0.01 mg/m2. And change as the sensitivity of the inspection method increases.

Assay

First method external standard method (recommended)

Unless otherwise specified, the reference solution and the headspace bottle for the test sample shall be placed in a special environment for 60 minutes. The same volume of gas in the headspace vial of the test sample and the control was accurately injected into the phase chromatograph. Record the chromatogram, measure the peak area, and calculate the content of each solvent in the test sample according to the external standard method. The control sample was injected three times in succession, and the relative deviation of three times was no more than 10%.

Note: If the residual amount of solvent does not meet the requirements, the second method should be used for determination.

Second method

The amount of the above reference solution was accurately measured by a micro-injector, and each of the five headspace bottles was injected into a quick-cap seal (the linear range was determined according to the actual content of the organic solvent to be tested), and the reference substance of different concentrations of the species was prepared. The reference and the headspace bottle of the test sample were respectively placed at 100 degrees for 60 minutes, and the same volume of gas for the test sample and the reference product was accurately injected into the color chromatograph. Record the chromatogram, measure the peak area, plot the peak area and the corresponding solvent concentration of the control variety, and separate the concentration of each solvent from the standard curve, and calculate the content of each solvent in the formula.

There are two kinds of methods for determining the residual amount of solvent in medicinal plastic bottles. It is recommended to use the external standard method. If the residual amount of the solvent does not meet the requirements, the second method should be used for the determination.

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