YBB 00312004-2015 English PDF (YBB00312004-2015)

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.