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eStability Validator

Expiration dates on drugs are determined from drug lifetimes measured by extensive testing. These drug stability tests are reported to FDA. To simplify submission of drug stability reports, the FDA, together with HL7, has developed an electronic (XML) format, often called eStability. These eStability reports require validation against business rules that cannot be expressed in the form of XML Schema 1.0. The additional rules are expressed in Schematron form.

The Prometheus eStability validator is an online tool for validating eStability instance (XML) files against both the eStability XML Schema and Schematron rules.


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