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The determination of residual solvents in pharmaceutical packaging materials method of standard curve method
by：Lisson
2020-10-25
Take five different concentrations of organic solvent comparison under test (
Linear range according to the actual sample under test of organic solvent content determine)
。
At 100 ℃ & plusmn;
2 ℃ constant temperature box maintain 60 minutes (
When necessary, according to material and solvent, under test is placed within the range 80 ~ 150 ℃ for 15 minutes and 60 minutes, decomposition temperature is higher than the solvent boiling point below materials as appropriate)
With preheating temperature to the same container the top 1 ml syringe extraction of gas into the gas chromatograph.
Measurement of peak area (
Or peak)
, draw peak area (
Peak)
The standard curve with the corresponding organic solvent quality.
Take the sample, according to the standard curve method 'at 100 ℃ & plusmn;
2 ℃ constant temperature box keep 60 minutes' operation.
According to the sample under test in the organic solvent peak area (
Peak)
, from the standard curve of the quality of the samples contained in the solvent, press type calculation.
X = m/W type: X-ray
-
-
Samples of solvent residue, mg/m2;
m -
-
-
To test the quality of the solvent, mg;
W -
-
-
Sample surface area/m2.
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