ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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(NIST) A specification or product that has been formally reviewed and agreed upon, that serves as the basis for further development, and that can be changed only through formal change control procedures.

Publication Source: FDA Glossary of Computerized System and Software Development Technology


In some analytical procedures a sample is dissolved in water or combined with other reagents for analysis. A “blank” or standard consisting of the same reagents may be analyzed without sample present. This provides a comparative reference point, or baseline, so that the test results can be attributed solely to the sample itself.

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