Inside Standards

The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.

A changing regulatory environment is on the horizon for excipient suppliers and users.

The United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.

Representatives from 17 nations sit down to decide upon standards-setting initiatives.

USP is revising key documents to make them easier to use.

USP applies metrological principles to the dissolution procedure alone and in collaborative studies to understand and minimize potential sources of variability.

Efforts to solicit new monographs have fallen behind the rate of NDA approvals, while analytical techniques have become outdated because of advances in analytical technologies.

USP's proposed General Chapter 1226 "Verification of Compendial Procedures" aims to provide guidance about the verification process.

USP monographs, if they are consistently observed and applied, can help reduce medical gas errors.

At its 2005 Convention, USP passed 13 resolutions that will help define the organization’s path for the next five years and represent the interests of its diverse constituency.

The USP prepares for its quinquennial conference in March.

A recent USP gathering generated creative suggestions for the March 2005 USP convocation.