In Defense of USP Singlet Testing

The United States Pharmacopeia should notchange its philosophicalposition on singlet testing. Some in the pharmaceutical industry have begun to question the philosophical underpinnings of the United States Pharmacopeia’s (USP) position on compendial standards and singlet testing.

That philosophical position is clearly stated in USP 28:
 Compendial standards define what is an acceptable article and give test procedures that demonstrate that the article is in compliance. These standards apply at any time in the life of the article from production to consumption. ... Thus, when tested from the viewpoint of commercial or regulatory compliance, any specimen tested as directed in the monograph for that article shall comply. ... Tests and assays in this Pharmacopeia prescribe operation on a single specimen, that is, the singlet determination, ….” (Italics added.) (1).

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