Compendial Compliance

Effective July 1, 2008, the Office of Generic Drugs (OGD) will require abbreviated new drug applications (ANDAs) to include data that demonstrate the manufacturer's control of residual solvents.

The authors demonstrate that anecdotal reports of prednisone tablet variability are inaccurate.

The authors survey the approved applications of dimethyl sulfoxide USP, PhEur across the healthcare industry and consider the suitability of DMSO from a regulatory and formulation compatibility standpoint.

The United States Pharmacopeial Convention (USP) has agreed to work with the US Food and Drug Administration on developing more sensitive tests for detecting contaminants such as over-sulfated chondroitin, which was found in batches of heparin last January.

A reference book omits important information and ignores advanced testing procedures.

Brief pharmaceutical news items for April 2008.

The US Pharmacopeial Convention announced a revised glycerin monograph in the United States Pharmacopeia.

The US Pharmacopeial Convention (USP) signed a Memorandum of Understanding (MOU) with the Chinese Pharmacopoeia Commission (ChP) designed to strengthen the quality of medicine and foods in the United States and China.

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

USP 467 Residual Solvents will take effect on July 1, 2008. But does the industry understand these specifications-and is it prepared?

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

Amidst debate, the European Pharmacopoeia Commission is working to include physical or "functionality-related characteristics" of exipient materials in its monographs.

Revisions to the United States Pharmacopeia's (USP) uniformity test require manufacturers to establish new acceptance limits. The authors present their method for calculating acceptance limits consistent with USP's revised content-uniformity test requirements.

Study results show that the state of a cleanroom clothing system–new or much used–influences the protection efficacy of the system.

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.

The United States Pharmacopeia should not change its philosophical position on singlet testing.

Comparative studies of the US Pharmacopeia (645) "Conductivity" and the European Pharmacopeia "Heavy Metals" tests were conducted to demonstrate that the USP method can determine the presence or absence of heavy metals in process water samples.

Pharmaceutical Science & Technology News

The authors dispel common misinterpretations of the United States Pharmacopeia.

A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.

Although the United States Pharmacopeia-National Formulary is an everyday reference book, the people and processes behind it are not so familiar.

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

USP ensures the microbiological quality of products by way of the development, proposal, and acceptance of general information chapters.