Office of Testing and Research

Federal Research Center
White Oak Office Building #22
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-1213 Fax: (301) 796-9859

Vincent L. Vilker, Ph.D., Director

• Mission
   
• Organization
   
  • Laboratory of Clinical Pharmacology
     
  • Division of Applied Pharmacology Research
     
  • Division of Pharmaceutical Analysis
     
  • Division of Product Quality Research
     
• Research Programs
  
   
•  Hot Topics
  • Method for at-site detection of Diethylene Glycol/Ethylene Glycol Contamination: Simple, At-Site Detection of Diethylene Glycol/Ethylene Glycol Contamination of Glycerin and Glycerin-Based Raw Materials by Thin-Layer Chromatography (PDF - 1.72MB) by Allen S. Kenyon
      
  • Documents related to enhanced mechanical calibration of dissolution apparatus:  Mechanical Qualification of Dissolution Apparatus. 1 and 2 (PDF - 159KB) (updated 6/1/2006)
     
  • The FDA is providing to the public a Thin Layer Chromatography (TLC) procedure that can be used as an initial screening procedure to detect the presence of Diethylene Glycol (DEG) in toothpaste: Identification of Diethylene Glycol (DEG) in Toothpaste by Thin Layer Chromatography (TLC) (PDF - 53KB)
     
  • The FDA is launching an initiative to enhance the screening of excipients and raw products using library based spectral correlation methods. If you would like to read more about the Agency’s efforts please refer to "FDA Introduces Spectral Library" which can be accessed via the Internet starting on July 7, 2011 at www.PharmTech.com and also appears in print in the July 2011 issue of Pharmaceutical Technology (Vol 35 Issue 7). If you are an excipient manufacturer or distributor and would like to participate in the study by providing samples to the Division of Pharmaceutical Analysis to populate the spectral library, please complete the Material Transfer Agreement (MTA) (PDF - 38KB) and contact Jason Rodriguez at: jason.rodriguez@fda.hhs.gov
    
    These documents are posted as examples and should not be viewed as an endorsement for or exclusion of any manufacturer of dissolution or measuring equipment.