ASTM Int'l Molecular Spectroscopy Committee Approves Multivariate Calibration Standard - ASTM E 2617
October 3, 2008 // Published as a news service by IHS
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ASTM International approved ASTM E 2617 - Practice for Validation of Empirically Derived Multivariate Calibrations to help provide a need for multivariate analytical techniques.
Subcommittee E13.11 on Multivariate Analysis, under the jurisdiction of ASTM International Committee E13 on Molecular Spectroscopy and Separation Science, developed ASTM E 2617.
According to Richard Kramer, founder and president, Applied Chemometrics Inc. and a member of Committee E13, several factors contributed to the use of multivariate analytical techniques in diverse industrial sectors such as petrochemical, agriculture, polymers, medical diagnostics and others.
These factors include the rise of more sophisticated but less expensive instrumentation and computers along with the competitive and economic needs to do things faster, better and cheaper.
"It is essential that practitioners and developers of multivariate analyzers and analytical techniques apply sufficient discipline in developing methods, qualifying them for deployment and monitoring performance on an ongoing basis," said Kramer.
"Prior to this standard, there has been no formal guidance on how to do this essential validation properly, in a way that rigorously characterizes performance with statistically quantifiable measures, which can be used in a risk-based strategy for design and reliance on empirically derived multivariate calibrations."
Kramer also said that pharmaceutical applications are among the most important, with ASTM Committee E55 on Manufacture of Pharmaceutical Products working on such proposed standards as ASTM WK9191 - Practices for Multivariate Analysis Related to Process Analytical Technology and ASTM WK20498 - Practice for Multivariate Statistical Process Control for Manufacturing Processes.
Subcommittee E13.11 welcomes input from all interested parties on the expansion of ASTM E 2617 in future revisions. "The standard contains an appendix that is intended to illustrate how it might be used in a pharmaceutical context," said Kramer. "We would welcome any suggestions or drafts for additional appendices that cover other application areas."
Source: ASTM International.