Heavyweight: The "Technical Regulations for Extractable Disposable Polymer Components in Pharmaceutical Processes" has been officially implemented!
Norms lead standards first
Methodology
Firstly, a semi quantitative method is used to determine all extractable substances, establish the AET of the method, and then identify extractable substances exceeding the AET. For extractable substances with confirmed structures, quantitative/semi quantitative determination is carried out using the reference substance/internal standard method.
Methodological confirmation of semi quantitative methods
The confirmation of semi quantitative methods focuses on the systematic applicability and sensitivity of the methods; For example, the GC-MS method selects appropriate standards to evaluate the system suitability and sensitivity (detection limit) of the instrument, and selects appropriate internal standards (extractable reference materials cannot be obtained or their structures cannot be fully confirmed) to establish a semi quantitative analysis method.
Methodological validation of quantitative methods
Comprehensive methodological validation was conducted on the extractable samples with determined structures using reference materials, including accuracy or recovery rate, precision (repeatability, intermediate precision), specificity, detection limit, quantification limit, linearity and range, etc.
Especially for scanning experiments, when a "semi quantitative method" is required, it is necessary to introduce system applicability standards and internal standards for monitoring the reliability and effectiveness of the method.In this guideline, based on the requirements of the elastomer compatibility guidelines mentioned above, it is further clarified which methodology to use for different detection and testing equipment, as well as which recommended standard to use to confirm the reliability of equipment and methods. It is an effective supplement to the compatibility guidelines for elastomers and guides future regulatory directions.
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