Since the early 1980s, multivariate analytical techniques have been increasingly used in a variety of industries. A new ASTM International standard, E2617, Practice for Validation of Empirically Derived Multivariate Calibrations, answers a need for standards for these techniques. Subcommittee E13.11 on Multivariate Analysis, under the jurisdiction of ASTM International Committee E13 on Molecular Spectroscopy and Separation Science, developed E2617.
According to Richard Kramer, founder and president, Applied Chemometrics Inc., and a member of Committee E13, several factors have contributed to the use of multivariate analytical techniques in diverse industrial sectors such as petrochemicals, 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,” says 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 notes that pharmaceutical applications are currently among the most important, with ASTM Committee E55 on Manufacture of Pharmaceutical Products working on such proposed standards as WK9191, Practices for Multivariate Analysis Related to Process Analytical Technology, and WK20498, Practice for Multivariate Statistical Process Control for Manufacturing Processes.
Subcommittee E13.11 welcomes input from all interested parties on the expansion of E2617 in future revisions. “The standard contains an appendix that is intended to illustrate how it might be used in a pharmaceutical context,” says Kramer. “We would welcome any suggestions or drafts for additional appendices that cover other application areas.”
Technical Information: Richard Kramer, Applied Chemometrics Inc., Sharon, Mass.
ASTM Staff: Joe Koury