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YBB 00312004-2015 (YBB00312004-2015)

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YBB 00312004-2015: PDF in English
YBB 00312004-2015
Test for Residual Solvent of Packaging Materials
Issued by. China Food and Drug Administration of PRC
Test for Residual Solvent of Packaging Materials
This Method applies to the determination of residual solvent of pharmaceutical packaging
materials. Residual solvent of pharmaceutical packaging materials refers to organic volatile
substances which are used in the raw and auxiliary materials and the production process,
but are not fully removed during the production process of pharmaceutical packaging
materials. The residual quantity of organic solvent in pharmaceutical packaging materials
shall be as specified for each product. The types of solvent to be tested shall be determined
in accordance with the characteristics of formulas and technologies of products; they are not
limited to the solvents described in this Standard.
This Method is based on a gas-solid equilibrium. Take a certain area of test specimen to
place into a sealed container; under certain conditions of temperature and time, the residual
organic solvent of test specimens is heated to become volatile; after an equilibrium is
achieved, take headspace gas quantitatively to inject into chromatograph for analysis to
retain time for qualitative analysis and peak area for quantitative analysis. Determine in
accordance with the method for the determination of residual solvent (general rule 0861 of
the fourth edition of Chinese Pharmacopoeia 2015); the limit of residual solvent shall be as
specified for all products, including the detection limit of the methods for benzene and each
solvent of benzenes not greater than 0.01 mg/m2, and it changes along with the improvement
of the sensitivity of test methods.
Chromatographic conditions and system applicability test
Chromatographic column may be capillary column or other appropriate chromatographic
columns which can meet the requirements for the separation of solvent to be tested. Use the
chromatographic peak of solution to be tested for calculation. The number of theoretical
plates of packed column is normally not lower than 1000.
Unless specified otherwise, capillary chromatographic columns of the same type with similar
polarities can be used interchangeably. The number of theoretical plates shall not be less
than 5000.
1. Nonpolar chromatographic columns. 100% dimethyl polysiloxane.
2. Polar chromatographic columns. polyethylene glycol PEG 20 M.
3. Moderate polar chromatographic columns. 6% cyanopropyl phenyl-94% dimethyl
4. Weak polar chromatographic columns. 5% phenyl-95% methyl polysilicone.
The following conditions are generally used.
Chromatographic column. INNOWAX (60 m × 0.32 mm × 0.5 μm);
Detector. flame ionization detector (FID);
Standard ID YBB 00312004-2015 (YBB00312004-2015)
Description (Translated English) Test for Residual Solvent of Packaging Materials
Sector / Industry Medical & Pharmaceutical Packaging Industry Standard
Classification of Chinese Standard C08
Word Count Estimation 3,393
Date of Issue 2015-08-11
Date of Implementation 2015-12-01
Older Standard (superseded by this standard) YBB 0031-2004
Regulation (derived from) China Food & Drug Administration Announcement 2015 No.164