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YBB60062012English135 Add to Cart 0--3 minutes. Auto-delivered. The Test Method for Residue of Solvent in Packaging Material

State Food and Drug Administration
of the People’s Republic of China
Direct contact with drug’s
packaging materials and containers standard
National Institutes for Food and Drug Control
Packaging Materials and Pharmaceutical Excipients Inspection Institute
December 2012
It can separate methanol, isopropanol, acetone, methyl ethyl ketone, ethyl acetate, butyl acetate,
benzene, toluene, ethylbenzene, p-xylene, o-xylene, m-xylene, etc.
Preparation of test samples
Unless otherwise specified, the samples are cut into size of 1cm × 3cm. Please in headspace
bottle. After adding 2 glass balls, Cover and seal it. Test 2 samples in parallel.
Preparation of reference solution
Respectively take appropriate amount of above organic solvent. Place in 50 mL volumetric flask
that contains about 40mL of dilution solvent (the solvent shall not interfere the determination of
all the components. It is recommended to use n-hexane). Add solvent to dilute to the mark. Shake
well and standby for spare use. Use micro-injector to accurately measure appropriate amount
(concentrations of each component shall be roughly equal to the specified limits. The total amount
shall not exceed the possible total amount in the sample). Inject into the headspace bottle that
has been covered and sealed. Test 3 samples in parallel.
Determination Method
The first method The external standard method (recommended)
Unless otherwise specified, take the headspace bottles that contains reference solution and test
sample. Respectively place them at 100 °C ± 2 °C for 60 minutes. Accurately measure the same
volume of gas from the headspace bottles that contains reference solution and test sample. Inject
into the gas chromatographs. Record the chromatograms. Measure the peak areas. Calculate
the contents of each solvents in test sample, according to the external standard method.
Note. If the solvent residues do not comply with the provisions, it shall re-prepare the reference solution of
which the content is equivalent to that of the actual detected solvent. Repeat the determination. Adopt The
Second Method to perform determination.
The second method Standard curve method
Use micro-injector to respectively measure appropriate amount of above reference solution.
Respectively inject into 5 headspace bottles that have already been covered and sealed (Linear
range is determined based on the actual content of the organic solvent of test sample). Prepare
to be 5 references with different concentration. The headspace bottles with reference and test
samples are respectively placed at 100 °C ± 2 °C. Maintain for 60min. Accurately measure the
same volume of gas of the test sample and reference. Inject into gas chromatographs. Record
the chromatograms. Measure the peak areas. Draw the standard curve of peak area TO the
corresponding solvent concentration in reference. Obtain the concentrations of each solvent from
the standard curve. And calculate the contents of each solvent in test sample.