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YBB 00312004-2015

Chinese Standard: 'YBB 00312004-2015'
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Standard ID YBB 00312004-2015 (YBB00312004-2015)
Description (Translated English) (Packaging materials solvent residue assays)
Sector / Industry Medical & Pharmaceutical Packaging Industry Standard
Classification of Chinese Standard C08
Word Count Estimation 2,260
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Older Standard (superseded by this standard) YBB 0031-2004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

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);

YB B00312004-2015
(Packaging materials solvent residue assays)
Determination of Solvent Residue of Packaging Materials
Baozhuangcailiao Rongji Canliuliang Cedingfa
Test for Residual Solvent of Packaging Materials
This method is applicable to the determination of residual solvents in pharmaceutical packaging materials. Residual solvent in the drug package refers to the raw material of the drug package
And organic volatiles used in the production process but which are not completely removed during the production of the drug packaging material. There are drugs in the package
The residual solvent should be in accordance with the provisions of each variety. Need to detect the type of solvent, should be based on product formulation process characteristics
It is determined that not only the solvents exemplified in this standard are limited.
This method is based on gas and solid balance, take a certain area of the sample placed in a sealed container, in a certain temperature and time
Pieces, the residual organic solvent in the sample heat and volatile, to balance, take the headspace gas into the chromatographic analysis,
To retain the time qualitative, peak area quantitative. According to the residual solvent assay ("Chinese Pharmacopoeia".2015 edition of the four general rules 0861)
Determination of the limits of residual solvents should meet the requirements of the various varieties, including benzene and benzene of each solvent method should not limit the detection limit
Which is higher than 0.01 mg/m2, and changes with the sensitivity of the test method.
Chromatographic conditions and system suitability The test column can be used to meet the requirements of the solvent separation of the capillary column or its
He is suitable for the column.
Calculated with the chromatographic peaks of the material to be measured, the number of packed column theoretical plates is generally not less than 1000.
In addition to the provisions of the capillary column, similar to the similar nature of the column can be used interchangeably. Number of theoretical boards. No
Less than 5000.
1. Non-polar column. 100% dimethylpolysiloxane.
2. Polar column. Polyethylene glycol PEG 20M.
3. Medium polar column. 6% aminopropylphenyl-94% dimethylpolysiloxane.
4. Weak polar column. 5% phenyl-95% methylpolysiloxane.
General selection.
Column. INNOWAX (60 m * 0.32 mm * 0.5 μm)
Detector. Flame Ionization Detector (FID).
Determination conditions (for reference). column temperature starting temperature 50 ℃, keep 5 minutes, then the temperature per minute 10 ℃ to
150 ℃, inlet temperature.200 ℃, detector temperature 220 ℃.
Split ratio. 10. 10
Nitrogen 2 ml/min, hydrogen 40 ml/min, air 400 ml/min.
Resolution. The separation of the chromatographic peaks and adjacent chromatographic peaks should be greater than 1.5.
The relative standard deviation of the peak area of the test object shall not be greater than 10%.
Can be separated from methanol, isopropyl alcohol, acetone, butanone, ethyl acetate, butyl acetate, benzene, toluene, ethylbenzene, p-xylene,
O-xylene, m-xylene and so on.
Preparation of the test sample Unless otherwise specified, the sample cut into 1 cm * 3 cm size, set the top empty bottle, add two glasses
After the beads, the gland, sealed, parallel test 2 copies.
Preparation of the reference solution The appropriate amount of the organic solvent was used to prepare about 40 ml of the diluted solvent (the solvent should be dry
Damage to all components of the determination, recommended the use of positive Anhui) 50 m1 volumetric flask, add solvent diluted to the mark, shake, spare.
Use the micro-injector to measure the amount of precision (the concentration of each component should be the same as the specified limit, the total should not be higher than the sample may be
Of the total amount), into the headspace bottle in the rapid gland seal, parallel test 3 copies.
Determination method
The first legal method (recommended)
Unless otherwise specified, add the reference solution and the test sample of the top of the bottle, were placed at 100 ℃ ± 2 ℃ to maintain 60 minutes
bell. The precise amount of the test sample and the reference substance in the headspace bottle in the same volume of gas into the gas chromatograph. Record the chromatogram,
Measuring the peak area, according to the external standard method for the test sample of the solvent content should meet the requirements. Reference substance for three consecutive injections, three times
The relative deviation of the results is no more than 10%.
Note. If the amount of the residue is not met, the second method should be used for the determination.
Related standard: YBB 00012005-1-2015    YBB 00012005-2-2015
Related PDF sample: YBB 00102003-2015    YBB 00122003-2015