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ASTM F 1884 : 2004 : R2023

Current

Current

The latest, up-to-date edition.

Standard Test Methods for Determining Residual Solvents in Packaging Materials

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

05-04-2023

1.1This test method covers determination of the amount of residual solvents released from within a packaging material contained in a sealed vial under a given set of time and temperature conditions and is a recommended alternative for Test Method F151.

1.2This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are retained in packaging materials.

1.3The analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate studies on the solvents of interest. The analyst is referred to Practice E260 for guidance.

1.4For purposes of verifying the identity of or identifying unknown volatile compounds the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy or other suitable techniques in conjunction with this test method.

1.5Sensitivity of this test method in the determination of the concentration of a given retained solvent must be determined on a case by case basis due to the variation in the substrate/solvent interaction between different types of samples.

1.6This test method does not address the determination of total retained solvents in a packaging material. Techniques such as multiple headspace extraction can be employed to this end. The analyst is referred to the manual supplied with the GC-Autosampling system for guidance.

1.7The values stated in SI units are to be regarded as the standard.

1.8This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.9This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Committee
F 02
DocumentType
Test Method
Pages
7
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

ASTM F 2097 : 2020 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ASTM F 2150 : 2019 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products

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