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August 02, 2008
The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
July 10, 2008
The European Pharmacopoeia Commission adopted revised monographs for heparin calcium and heparin sodium to strengthen the level of testing required for quality control.
July 03, 2008
After a one-year delay in its implementation, the US Pharmacopeia Chapter 467 "Residual Solvents" is now official.
June 26, 2008
The US Pharmacopeia (USP) posted revised monographs for heparin sodium and heparin calcium on its website.
June 19, 2008
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.
June 02, 2008
The authors demonstrate that anecdotal reports of prednisone tablet variability are inaccurate.
May 02, 2008
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.
April 22, 2008
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.
April 02, 2008
A reference book omits important information and ignores advanced testing procedures.
Brief pharmaceutical news items for April 2008.