YBB 00312004-2015 PDF EnglishUS$100.00 · In stock · Download in 9 seconds
YBB 00312004-2015: Test for Residual Solvent of Packaging Materials Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYBB 00312004-2015: Test for Residual Solvent of Packaging Materials---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YBB00312004-2015YY / YBB PETROCHEMICAL INDUSTRY STANDARD Test for Residual Solvent of Packaging Materials Issued on: AUGUST 11, 2015 Implemented on: DECEMBER 01, 2015 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 polysiloxane. 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); ...... Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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