Analytical, Characterization and Stability Studies of Chemicals, Bulk Drugs and Drug Formulations
Abstract
The overall purpose of this contract was to perform chemical/physical analyses on bulk pharmaceutical substances and formulated drug products of interest to the USAMRMC Drug Development Program for parasitic and infectious diseases, chemical and biological defense, etc. Specific objectives were to design, develop, validate, and apply methods to determine chemical and physical characteristics on bulk drug and drug products. For the entire contract period, 1 August 1991 to 30 June 1997, 125 samples of bulk drugs and dosage formulations were analyzed for identity, purity or potency; 133 samples were studied for stability and solubility. Four chiral separation methods were developed and validated, and 11 other chemical assay methods were validated. Special projects included the development and application of assays for determining protein content, residual solvents, and other relevant components in microsphere vaccine preparations. A second special project was the development and application of an assay for determining bis(chloromethyl) ether in HI-6 bulk drugs. Posters were presented in the 1993 and 1996 Medical Defense Bioscience Reviews. One publication appeared in press and a second has been accepted for publication.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 1997
- Accession Number
- ADB233658
Entities
People
- Peter Lim
Organizations
- SRI International