Medicinal plastic bottle with child proof cap solvent residue

The residual solvent of the plastic bottle with child proof cap 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.

plastic bottle with pressure cap

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. Moreover, it changes as the sensitivity of the inspection method increases.

Assay

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%.